A Church-Based Weight Loss Intervention in African American Adults using Text Messages (LEAN Study): Cluster Randomized Controlled Trial.

BACKGROUND: African American adults experience a high prevalence of obesity and its associated comorbidities, including diabetes. Church-based interventions have been shown to be effective in decreasing weight in this population. mHealth interventions can address two needs for obesity treatment in this community, including enhancing weight loss and providing wide dissemination. OBJECTIVE: This study aimed to assess the feasibility and efficacy of a church-based weight loss intervention that incorporates mHealth technology. METHODS: In this study, 8 churches (n=97) were randomly assigned to the intervention or delayed intervention condition (control group). We recruited participants through their respective church. Volunteer church members were trained by study staff to deliver the 10-session, 6-month intervention. Participants in the intervention group attended group sessions and received automated short message service (SMS) text messages designed to reinforce behavioral strategies. Conversely, participants in the delayed intervention condition received SMS text messages related to health conditions relevant for African American adults. We obtained measures of body composition, blood pressure, blood glucose, and cholesterol. RESULTS: We successfully recruited 97 African American adults, with a mean age of 56.0 (SE 10.3) years and a mean body mass index of 38.6 (SE 6.4) kg/m2 (89/97, 91.8% females), who attended the churches that were randomized to the intervention (n=68) or control (n=29) condition. Of these, 74.2% (72/97) of the participants (47/68, 69.1% intervention; 25/29, 86.2% delayed intervention) completed the 6-month assessment. The average intervention group attendance was 55%. There was a significant difference in weight loss (P=.04) between participants in the intervention (-1.5 (SE 0.5) kg) and control (0.11 (SE 0.6) kg) groups. Among participants in the intervention group, the correlation between the number of SMS text messages sent and the percent body fat loss was r=.3 with P=.04. The participants reported high satisfaction with the automated SMS text messages. CONCLUSIONS: Automated SMS text messages were well-received by participants, suggesting that more enhanced mHealth technologies are a viable option for interventions targeting African American adults. TRIAL REGISTRATION: ClinicalTrials.gov NCT02863887; https://clinicaltrials.gov/ct2/show/NCT02863887 (Archived by WebCite at http://www.webcitation.org/71JiYzizO).

Recruiting African American Churches to Participate in Research: The Learning and Developing Individual Exercise Skills for a Better Life Study.

Physical activity among African Americans (AA) is low; effective intervention strategies are needed. Community-based settings are useful for delivering health-related interventions in racial/ethnic minority communities. This article describes strategies used to recruit churches for participation in a 22-month intervention designed to increase physical activity levels in AA women. Initial recruitment efforts, led by AA study staff, included direct mailers, phone calls, and in-person meetings with church representatives. After 10 months, only five churches were enrolled. Seven community members with existing partnerships/contacts in the faith community were subsequently hired and an additional 26 churches were enrolled within 6 months. Overall response rate was 45%, and churches required 3.5 ± 3.0 months of multiple contacts prior to enrollment. The main primary contacts within churches were individuals with personal interest in the program and pastors. Prior relationship between the research team and churches did not appear to influence church enrollment as much as community member recruiters. The current study identifies several potential strategies that may be useful for increasing success in efforts to recruit AA churches into studies. Additional research is warranted that tests and compares a variety of recruitment strategies to determine the most successful strategies for recruitment in different populations.

Challenges to recruitment and retention of African Americans in the gene-environment trial of response to dietary interventions (GET READI) for heart health.

In this paper, challenges to recruiting African Americans specifically for a dietary feeding trial are examined, learning experiences gained and suggestions to overcome these challenges in future trials are discussed. A total of 333 individuals were randomized in the trial and 234 (167 sibling pairs and 67 parents/siblings) completed the dietary intervention and required DNA blood sampling for genetic analysis. The trial used multiple strategies for recruitment. Hand distributed letters and flyers through mass distribution at various churches resulted in the largest number (n = 153, 46%) of African Americans in the trial. Word of mouth accounted for the second largest number (n = 120, 36%) and included prior study participants. These two recruitment sources represented 82% (n = 273) of the total number of individuals randomized in GET READI. The remaining 18% (n = 60) consisted of a combination of sources including printed message on check stubs, newspaper articles, radio and TV appearances, screening events and presentations. Though challenging, the recruitment efforts for GET READI produced a significant number of African American participants despite the inability to complete the trial as planned because of low recruitment yields. Nevertheless, the recruitment process produced substantial numbers that successfully completed all study requirements.

Academic partnerships and key leaders emerging from communities in the lower Mississippi Delta (LMD): a community-based participatory research model.

Collaboratively, the nutritional health problems of the Lower Mississippi Delta (LMD) region were examined and opportunities identified for conducting research interventions. To combat the nutritional health problems in the LMD, community residents yielded to a more comprehensive and participatory approach known as community-based participatory research (CBPR). Community residents partnered with academic researchers and other organizational entities to improve the overall quality of diet and health in their respective communities using CBPR. The collaborative work in the LMD focused on interventions conducted in each of three specific communities across three states: Marvell, Arkansas (Marvell NIRI), and its surrounding public school district; Franklin Parish in Louisiana (Franklin NIRI); and the city of Hollandale, Mississippi (Hollandale NIRI). This paper examined some of the research interventions conducted in Franklin, Hollandale, and Marvell NIRI respectively, how leadership emerged from each of these communities, and lessons learned as a result of the CBPR model.

Perceptions of a Pragmatic Family-Centered Approach to Childhood Obesity Treatment.

Background: Few studies have examined both parent and child preferences regarding family-based weight management programs (WMPs) delivered in primary care settings, especially among racial minority populations. The purpose of this study was to determine the perceptions that parents and their children/adolescents have about the components that should be included in a family-based WMP and to identify perceived preferences, benefits, and/or barriers to participation. Methods: A sample of 60 participants (30 parents and 30 children/adolescents) participated in 1 of 5 separate structured focus groups, using probing questions and the nominal group technique (NGT). Parents reported demographics for themselves and their children/adolescents. Themes from probing questions were identified using thematic analysis. Results: Parents were primarily African American (93%) and diverse in income. NGT sessions revealed that parents across all groups perceived that education on healthy eating, parental involvement, and effective program leaders are most important and have the greatest impact, while parental involvement was perceived as the easiest method to implement in a family-based WMP for childhood obesity. Children/adolescents perceived that education on healthy eating and exercise would have the greatest impact, while healthy eating and meal plans were perceived as the easiest methods to implement with a family. Parents and children/adolescents also identified improved psychological well-being (eg, decreased bullying, increased self-esteem, and motivation) as a desired program outcome. Conclusion: Parents and their children/adolescents highlighted the importance of physical and psychological health as targets in treatment. Feedback from patients can inform the design and implementation of family-based WMPs delivered in primary care settings.

Associations of internet website use with weight change in a long-term weight loss maintenance program.

BACKGROUND: The Weight Loss Maintenance Trial (WLM) compared two long-term weight-maintenance interventions, a personal contact arm and an Internet arm, with a no-treatment control after an initial six-month Phase I weight loss program. The Internet arm focused on use of an interactive website for support of long-term weight maintenance. There is limited information about patterns of website use and specific components of an interactive website that might help promote maintenance of weight loss. OBJECTIVE: This paper presents a secondary analysis of the subset of participants in the Internet arm and focuses on website use patterns and features associated with long-term weight maintenance. METHODS: Adults at risk for cardiovascular disease (CVD) who lost at least 4 kilograms in an initial 20-week group-based, behavioral weight-loss program were trained to use an interactive website for weight loss maintenance. Of the 348 participants, 37% were male and 38% were African American. Mean weight loss was 8.6 kilograms. Participants were encouraged to log in at least weekly and enter a current weight for the 30-month study period. The website contained features that encouraged setting short-term goals, creating action plans, and reinforcing self-management habits. The website also included motivational modules, daily tips, and tailored messages. Based on log-in and weight-entry frequency, we divided participants into three website use categories: consistent, some, and minimal. RESULTS: Participants in the consistent user group (n = 212) were more likely to be older (P = .002), other than African American (P = .02), and more educated (P = .01). While there was no significant difference between website use categories in the amount of Phase I change in body weight (P = .45) or income (P = .78), minimal website users (n = 75) were significantly more likely to have attended fewer Phase I sessions (P = .001) and had a higher initial body mass index (BMI) (P < .001). After adjusting for baseline characteristics including initial BMI, variables most associated with less weight regain included: number of log-ins (P = .001), minutes on the website (P < .001), number of weight entries (P = .002), number of exercise entries (P < .001), and sessions with additional use of website features after weight entry (P = .002). CONCLUSION: Participants defined as consistent website users of an interactive behavioral website designed to promote maintenance of weight loss were more successful at maintaining long-term weight loss. TRIAL REGISTRATION: NCT00054925; http://clinicaltrials.gov/ct2/show/NCT00054925 (Archived by WebCite at http://www.webcitation.org/5rC7523ue).

The Design of a Randomized Clinical Trial to Evaluate a Pragmatic and Scalable eHealth Intervention for the Management of Gestational Weight Gain in Low-Income Women: Protocol for the SmartMoms in WIC Trial.

BACKGROUND: Less than one-third of women gain an appropriate amount of weight during pregnancy, which can influence the long-term health of both the mother and the child. Economically disadvantaged women are the most vulnerable to maternal obesity, excessive weight gain during pregnancy, and poor birth outcomes. Effective and scalable health care strategies to promote healthy weight gain during pregnancy specifically tailored for these women are lacking. OBJECTIVE: This paper presents the design and protocol of a biphasic, community-based eHealth trial, SmartMoms in WIC, to increase the adherence to healthy gestational weight gain (GWG) recommendations in low-income mothers receiving women, infant, and children (WIC) benefits. METHODS: Phase 1 of the trial included using feedback from WIC mothers and staff and participants from 2 community peer advisory groups to adapt an existing eHealth gestational weight management intervention to meet the needs of women receiving WIC benefits. The health curriculum, the format of delivery, and incentive strategies were adapted to be culturally relevant and at an appropriate level of health literacy. Phase 2 included a pragmatic randomized controlled trial across the 9 health care regions in Louisiana with the goal of enrolling 432 women. The SmartMoms in WIC intervention is an intensive 24-week behavioral intervention, which includes nutrition education and exercise strategies, and provides the technology to assist with weight management, delivered through a professionally produced website application. RESULTS: Phase 1 of this trial was completed in July 2019, and recruitment for phase 2 began immediately thereafter. All data are anticipated to be collected by Spring 2023. CONCLUSIONS: The SmartMoms in WIC curriculum was methodically developed using feedback from community-based peer advisory groups to create a culturally relevant, mobile behavioral intervention for mothers receiving WIC benefits. The randomized clinical trial is underway to test the effectiveness of a sustainable eHealth program on the incidence rates of appropriate GWG. SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC. TRIAL REGISTRATION: ClinicalTrials.gov NCT04028843; https://clinicaltrials.gov/ct2/show/NCT04028843. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18211.

The "Rolling Store:" an economical and environmental approach to the prevention of weight gain in African American women.

OBJECTIVE: To test the feasibility of the "Rolling Store," an innovative food-delivery intervention, along with a nutrition education program to increase the consumption of healthy foods (fruits and vegetables) to prevent weight gain in African American women. METHODS: Forty eligible African American women were enrolled in the study and randomized to intervention or control groups. A trained peer educator and a Rolling Store operator implemented the study protocol at a local community center. RESULTS: The program retention rate was 93%. Participants in the intervention group lost a mean weight of 2.0 kg, while participants in the control group gained a mean weight of 1.1 kg at six months. Overall participants showed a mean decrease in weight of -.4 kg (standard deviation 3.0 kg), but the intervention group lost significantly more weight and had a decreased body mass index at six months. In the intervention group, the average number of servings consumed per day of fruits/ fruit juice and vegetables significantly increased at six months. CONCLUSIONS: The Rolling Store, at least on the small scale on which it was implemented, is a feasible approach to producing weight loss and improvements in healthy eating when combined with an educational program in a small community center.

Recruiting African American girls and parents for a secondary weight gain prevention study.

This research report describes the process and results of recruiting African American adolescent girls and parents for a secondary weight gain prevention study. We sought to recruit 60 girls with equal representation of at-risk for overweight (BMI percentile 85-95) and overweight (BMI > 95th percentile), and at least one obese (BMI > 30 kg/m2) parent. A personal and individual recruitment approach was the sole method utilized for recruitment of participants into this two-year Internet-based study targeting weight gain prevention. Participants were randomized to either an interactive behavioral condition or a health-based education (control) condition. Fifty-seven African American adolescent girls and their parents were enrolled in the study conducted at a university-based nutrition research center. One hundred eight adolescent girls volunteered and met the study criteria on the first contact, 95 interviewed in the clinic, 64 were randomized, and 57 (89%) of those randomized began the study. Seven percent of the study sample was comprised of African American girls at-risk for overweight, while the majority (93%) of those enrolled were overweight (BMI > 95th percentile). Our study sample comprised an imbalanced number of overweight versus at-risk for overweight African American girls suggesting that perhaps a clinic-based secondary weight gain prevention study may be an inefficient and ineffective setting for recruiting this population. Although we were successful in recruiting a majority of overweight girls, we conclude that the imbalance in the number of participants recruited is likely related to the sociocultural environment that predisposes African American girls to obesity and a lack of awareness by the parents' of the consequences of being overweight.

Cultural characteristics of African Americans: implications for the design of trials that target behavior and health promotion programs.

OBJECTIVE: To identify African American cultural characteristics that may be used to modify clinical trial designs and behavioral programs aimed at losing weight and maintaining weight loss. DESIGN: Focus group discussions. SETTING: University-affiliated biomedical research center. PARTICIPANTS: Thirty-one African American men and women who completed the screening process, but were ineligible for the Weight Loss Maintenance (WLM) trial, participated in one of five focus group sessions. WLM is a randomized controlled trial that compares two lifestyle interventions for preventing weight regain in individuals who have successfully lost weight in a group-based behavioral weight loss program. RESULTS: Nine themes emerged as cultural characteristics specific to African Americans seeking participation in a lifestyle change program: (1) religion is a powerful force; (2) family structure; (3) integration dismantled the African American family; (4) general mistrust of Caucasians; (5) African Americans are undervalued and not respected as a people; (6) limited resources equal limited ability to make lifestyle changes; (7) preservation of an explicit ethnic identity; (8) education is the key to success as an African American; and (9) communication skills are vital. CONCLUSIONS: Identifying cultural characteristics specific to African Americans may help investigators design clinical trials that will enhance outcomes and improve the generalizability of results in ethnic minority populations.

Clinical research trials: factors that influence and hinder participation.

The objective of this study was to examine factors that influence and hinder participation of African Americans in clinical research trials. Specifically, we examined and compared the perceived advantages and disadvantages to participation in clinical research trials, exposure to selected experiences prior to participation (i.e., who and what influenced the decision to participate or not), and perceptions regarding necessary preparation for participation in clinical research trials. Three hundred eighty six African Americans responded to the questionnaire that was administered in the study. As expected, African Americans who had previously participated in a clinical research trial agreed with factors perceived as advantages to participation, while respondents who had not previously participated endorsed factors perceived as potential disadvantages to participation in clinical research trials.

Healthcare Providers versus Patients' Understanding of Health Beliefs and Values.

OBJECTIVE: This study examined how well healthcare providers perceive and understand their patients' health beliefs and values compared to patients' actual beliefs, and to determine if communication relationships maybe improved as a result of healthcare providers' understanding of their patients' illness from their perspective. METHODS: A total of 61 participants (7 healthcare providers and 54 patients) were enrolled in the study. Healthcare providers and patients individually completed survey instruments and each participated in a structured focus group. RESULTS: Healthcare provider and patient differences revealed that patients perceived greater meaning of their illness (p = 0.038), and a greater preference for partnership (p = 0.026) compared to providers. The three qualitative themes most important for understanding patients' health beliefs and values as perceived by healthcare providers were education, trust, and culture. Educating patients was perceived as having the greatest impact and also the easiest method to implement to foster providers' understanding, with at least one patient focus group in agreement of same. Likewise, three themes were derived from patients' perspectives as relatively more important in understanding providers' beliefs and values; bidirectional communication, comprehensive treatment, and discipline. Overwhelmingly, bidirectional communication was perceived as a critical factor as having the greatest impact and may also be easiest to implement according to these patients. CONCLUSION: When patients and healthcare providers listen and communicate with each other, they are likely to develop a shared understanding that may improve future decision making and quality of care patients receive.

Exploring Patient, Caregiver, and Healthcare Provider Perceptions of Caring for Patients With Heart Failure: What Are the Implications?

BACKGROUND: Heart failure (HF) is an incurable and frequently progressive disease. Symptoms of HF may impair the ability of patients to perform daily living activities. As HF progresses, patients typically increase their reliance on caregivers. The purpose of this study was to determine what roles patients and caregivers perceive and desire for themselves in managing HF and to compare and contrast these roles with those perceived by healthcare providers. METHODS: A purposive sample (60 patients, 22 caregivers, and 11 healthcare providers) was enrolled in the study. Patients and caregivers individually participated in semistructured interviews, and healthcare providers participated in 1 of 2 focus groups. RESULTS: Four key themes evolved from interviews with patients and caregivers-education on disease specifics, guidance to enhance quality of life, learning to cope with HF, and future outlook and care decisions-that may guide the development of caregiver interventions in HF. Healthcare providers in both structured focus groups regardless of rank order selected knowledge is powerful, adherence to treatment plan, and compliance with medication as the top 3 issues likely to have the greatest impact, and they identified education on the disease (knowledge is powerful) as the easiest strategy to implement for patients and caregivers in the management of HF. CONCLUSION: Interventions among caregivers of patients with HF are needed and should focus on education in family structures, family functioning, and skills training in family assessment and engagement.

Perceptions of Obesity Treatment Options Among Healthcare Providers and Low-Income Primary Care Patients.

BACKGROUND: Primary care is a key component of medical care delivery and has a role to play in reducing obesity in the United States. The purpose of this study was to explore attitudes and perceptions about obesity in low-income primary care patients and to identify preferences for weight management interventions from the patient and healthcare provider perspectives. METHODS: A convenience sample of 28 patients and 6 healthcare providers from across the state of Louisiana participated in 1 of 5 structured focus groups. Demographic information was collected from both the patients and healthcare providers using survey instruments. RESULTS: Patients and healthcare providers were more similar than dissimilar in their perceptions of obesity in that both groups selected referral to a nutritionist, use of medication, and prescribed exercise as the top 3 strategies that would have the greatest impact on losing weight. Referral to a nutritionist was selected as the easiest strategy to implement. CONCLUSION: Receiving feedback from both patients and healthcare providers gives researchers the opportunity to acquire useful knowledge that may be beneficial in designing and conducting interventions suitable for patients desiring to lose weight, especially those in primary care settings.

Successfully recruiting a multicultural population: the DASH-Sodium experience.

Recruiting practices employed by the four clinical centers participating in the Dietary Approaches to Stop Hypertension (DASH)-Sodium trial were examined to assess the most successful method of obtaining participants and to describe pertinent learning experiences gained as a result of the trial. The primary recruitment strategies employed by each center were mass mailing brochures (direct, coupon packs, or other) and mass media (advertisements in newspapers, radio, and television spots). Of 412 randomized participants, 265 (64%) were from mass distribution of brochures, 62 (15%) mass media, and 85 (21%) were prior study participants, referred by word-of-mouth, or reported coming from screening events and presentations. Although the most successful method of recruitment was mass mailing brochures, three times as many brochures were distributed to obtain similar success as in the initial DASH trial.

A pilot church-based weight loss program for African-American adults using church members as health educators: a comparison of individual and group intervention.

OBJECTIVE: The purpose of this study was to examine a church-based intervention employing a 6-month pilot weight loss program as a strategy to improve health of African-American adults. DESIGN: A randomized trial design was used without a control group. Eligible church members were randomized into two groups: an intervention delivered in the group setting and an intervention delivered in the individual setting. SETTING: The study was conducted at an African-American church in Baton Rouge, Louisiana. PARTICIPANTS: Forty church members were enrolled in the study. Two trained church members without specialization in obesity treatment conducted the study. MAIN OUTCOME MEASURES: The primary outcome measure was weight loss. RESULTS: The program retention rate was 90%. After six months, a modest but significant mean weight loss was seen in all participants of 3.3 kg. The mean weight losses in the individual and group interventions were 3.4 kg and 3.1 kg, respectively. The mean body fat loss was 2.1 kg and 1.9 kg, respectively. The difference in weight loss and fat loss between the individual and group interventions was not statistically significant. An improvement in the quality of life and an increase in physical activity were reported by the program participants. CONCLUSIONS: A church setting may provide an effective delivery mechanism for a health and nutrition program. Church members may be trained to conduct a weight control program. Both interventions (individual and group) were effective in inducing weight loss.

Obtaining the Patient's Voice from within Three Patient-Centered Medical Homes.

The purpose of this qualitative program was to determine if a trend exists across three LSU medical homes according to patient feedback concerning their experiences within the medical home for ongoing disease management and quality healthcare; and to obtain recommendations for the most effective way to involve patients in shaping system policies, procedures, and practices consistent with patient and family-centered care principles. A total of 94 adult patients participated in either cognitive interviews (n = 45) or structured focus groups (n = 49) using the Nominal Group Technique (NGT). Exit surveys collected demographic information and feedback from patients about opportunities for their involvement in shaping medical homes. Cognitive interviews and NGT sessions both revealed some patient-perceived gratifications (i.e., friendliness and helpfulness of the clinic staff), and deficiencies (i.e., improving scheduling of appointments and reducing wait time in the clinic) within these medical homes. However, the perceived gratifications far exceeded the deficiencies found within each of three LSU medical homes.

Baton Rouge Healthy Eating and Lifestyle Program (BR-HELP): A Pilot Health Promotion Program.

Preventing weight gain rather than treating recognized obesity is an important economic and public health response to the growing levels of obesity nationwide. Community centers offer potential sites for community health promotion programs targeting African Americans. In this article, results from a pilot health promotion program at a community center are reported. The purpose of this 12-month pilot program was to improve diet and increase physical activity to prevent weight gain in African-American adults by delivering a lifestyle intervention. Fifty-one African-American adults were randomized into two groups: lifestyle intervention or financial counseling, and 73% completed the program. At the end of 12 months, weight for all participants was maintained from baseline to completion with no significant differences between the groups. Both lifestyle intervention and financial counseling groups were approximately 87% food secure with improvements observed in self-esteem and total quality of life scores.

Clinical research trials: a comparison of African Americans who have and have not participated.

The purpose of this is study was to gain an understanding of the knowledge and perceptions African Americans have that influence decisions to participate or not participate in clinical research trials. A survey instrument designed to measure the key variables; knowledge and perceptions of clinical research processes, and selected demographic characteristics were utilized in this study. The major finding suggests that African Americans who have been participants in a clinical trial are more likely to participate in future clinical trials if details are provided in advance concerning the requirements and criteria for their participation.

People United to Sustain Health (PUSH): a community-based participatory research study.

The prevention of weight gain to address the obesity epidemic rather than weight loss involves promoting small changes in food choices and physical activity. People United to Sustain Health (PUSH) was designed to increase fruit and vegetable consumption, physical activity, and food security to prevent weight gain in rural adults. Forty-nine participants were randomized into a treatment group which received access to a "Rolling Store," nutrition education and physical activity, and a control group which received family coping classes. Forty-one (84%) of participants completed the study. At the end of 6 months, weight for all participants was maintained from baseline to completion with no significant differences between the groups. The mean fruit consumption over 6 months for the treatment group increased and was significantly greater than change in the control group (p = 0.01). This community-based participatory research study was considered successful because weight gain was prevented.