A Method to Deliver Automated and Tailored Intervention Content: 24-month Clinical Trial.

BACKGROUND: The use of digital technologies and software allows for new opportunities to communicate and engage with research participants over time. When software is coupled with automation, we can engage with research participants in a reliable and affordable manner. Research Electronic Data Capture (REDCap), a browser-based software, has the capability to send automated text messages. This feature can be used to automate delivery of tailored intervention content to research participants in interventions, offering the potential to reduce costs and improve accessibility and scalability. OBJECTIVE: This study aimed to describe the development and use of 2 REDCap databases to deliver automated intervention content and communication to index participants and their partners (dyads) in a 2-arm, 24-month weight management trial, Partner2Lose. METHODS: Partner2Lose randomized individuals with overweight or obesity and cohabitating with a partner to a weight management intervention alone or with their partner. Two databases were developed to correspond to 2 study phases: one for weight loss initiation and one for weight loss maintenance and reminders. The weight loss initiation database was programmed to send participants (in both arms) and their partners (partner-assisted arm) tailored text messages during months 1-6 of the intervention to reinforce class content and support goal achievement. The weight maintenance and reminder database was programmed to send maintenance-related text messages to each participant (both arms) and their partners (partner-assisted arm) during months 7-18. It was also programmed to send text messages to all participants and partners over the course of the 24-month trial to remind them of group classes, dietary recall and physical activity tracking for assessments, and measurement visits. All text messages were delivered via Twilio and were unidirectional. RESULTS: Five cohorts, comprising 231 couples, were consented and randomized in the Partner2Lose trial. The databases will send 53,518 automated, tailored text messages during the trial, significantly reducing the need for staff to send and manage intervention content over 24 months. The cost of text messaging will be approximately US $450. Thus far, there is a 0.004% known error rate in text message delivery. CONCLUSIONS: Our trial automated the delivery of tailored intervention content and communication using REDCap. The approach described provides a framework that can be used in future behavioral health interventions to create an accessible, reliable, and affordable method for intervention delivery and engagement that requires minimal trial-specific resources and personnel time. TRIAL REGISTRATION: ClinicalTrials.gov NCT03801174; https://clinicaltrials.gov/ct2/show/NCT03801174?term=NCT03801174.

Use of Text Messaging and Facebook Groups to Support the Healthy Children, Strong Families 2 Healthy Lifestyle Intervention for American Indian Families.

BACKGROUND: Few obesity interventions have been developed for American Indian (AI) families despite the disproportionate risk of obesity experienced within AI communities. The emergence of mobile technologies to enhance intervention delivery could particularly benefit AI communities, many of which are hard to reach and underserved. OBJECTIVES: This study aimed to assess the use and perceptions of text messaging and Facebook to support delivery of the Healthy Children, Strong Families 2 (HCSF2) mailed healthy lifestyle/obesity prevention intervention and discuss lessons learned regarding intervention support via these platforms among AI participants. METHODS: From among AI families with young children (ages 2-5 y), 450 adult-child dyads were recruited from 5 rural and urban communities for a year-long intervention. Intervention content was delivered by mail and supported by text messaging and optional Facebook groups. Participants provided feedback on text message and Facebook components post-intervention, and Facebook analytic data were tracked. RESULTS: Self-report feedback indicated high satisfaction with both text messaging and Facebook, with tangible content (e.g., recipes, physical activity ideas) cited as most useful. Overall, participants reported higher satisfaction with and perceived efficacy of Facebook content compared with text messaging. Analytic data indicate the optional HCSF2 Facebook groups were joined by 67.8% of adult participants. Among those who joined, 78.4% viewed, 50.8% "liked," and 22.6% commented on ≥1 post. Engagement levels differed by urban-rural status, with more urban participants "liking" (P = 0.01) and commenting on posts (P = 0.01). Of note, nearly one-third of participants reported changing phone numbers during the intervention. CONCLUSIONS: This study demonstrates high satisfaction regarding mobile delivery of HCSF2 intervention support components. Best practices and challenges in utilizing different mobile technologies to promote wellness among AI families are discussed, with particular focus on urban-rural differences. Future mobile-based interventions should consider the context of unstable technology maintenance, especially in low-resource communities.This work is part of the HCSF2 trial, which is registered at clinicaltrials.gov (NCT01776255).

Protocol for Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss.

BACKGROUND: Behavioral interventions produce clinically significant weight reduction, with many participants regaining weight subsequently. Most interventions focus on an individual, but dietary and physical activity behaviors occur with, or are influenced by, domestic partners. According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change. We utilized interdependence theory to develop a partner-assisted intervention to increase long-term weight loss. METHODS: Community-dwelling individuals (index participants) cohabitating with a partner with 1) overweight and at least one obesity-related comorbidity or 2) obesity are randomized to participate in a standard weight management program alone or with their partner. The weight management program involves biweekly, in-person, group sessions focusing on weight loss for six months, followed by three group sessions and nine telephone calls focusing on weight loss maintenance for twelve months. In the partner-assisted arm, partners participate in half of the group sessions and telephone calls. Couples receive training in principles of cognitive behavioral therapy for couples, including sharing thoughts and feelings and joint problem solving, to increase communal coping. The primary outcome is participant weight loss at 24 months, with caloric intake and moderate-intensity physical activity as secondary outcomes. Partner weight and caloric intake will also be analyzed. Mediation analyses will examine the role of interdependence variables and social support. DISCUSSION: This trial will provide knowledge about effective ways to promote long-term weight loss and the role of interdependence constructs in weight loss. Clinical trials identifier: NCT03801174.

The Healthy Children, Strong Families 2 (HCSF2) Randomized Controlled Trial Improved Healthy Behaviors in American Indian Families with Young Children.

BACKGROUND: American Indian (AI) families experience a disproportionate risk of obesity due to a number of complex reasons, including poverty, historic trauma, rural isolation or urban loss of community connections, lack of access to healthy foods and physical activity opportunities, and high stress. Home-based obesity prevention interventions are lacking for these families. OBJECTIVE: Healthy Children, Strong Families 2 (HCSF2) was a randomized controlled trial of a healthy lifestyle promotion/obesity prevention intervention for AI families. METHODS: Four hundred and fifty dyads consisting of an adult primary caregiver and a child ages 2 to 5 y from 5 AI communities were randomly assigned to a monthly mailed healthy lifestyle intervention toolkit (Wellness Journey) with social support or to a child safety control toolkit (Safety Journey) for 1 y. The Wellness Journey toolkit targeted increased fruit/vegetable (F/V) intake and physical activity, improved sleep, decreased added sugar intake and screen time, and improved stress management (adults only). Anthropometrics were collected, and health behaviors were assessed via survey at baseline and at the end of Year 1. Adults completed surveys for themselves and the participating child. Repeated measures analysis of variance was used to assess change over the intervention period. RESULTS: Significant improvements to adult and child healthy diet patterns, adult F/V intake, adult moderate-to-vigorous physical activity, home nutrition environment, and adult self-efficacy for health behavior change were observed in Wellness Journey compared with Safety Journey families. No changes were observed in adult body mass index (BMI), child BMI z-score, adult stress measures, adult/child sleep and screen time, or child physical activity. Qualitative feedback suggests the intervention was extremely well-received by both the families and our community partners across the 5 participating sites. CONCLUSIONS: This multi-site community-engaged intervention addressed key gaps regarding family home-based approaches for early obesity prevention in AI communities and showed several significant improvements in health behaviors. Multiple communities are working to sustain intervention efforts. This trial was registered at clinicaltrials.gov as NCT01776255.

Household food insecurity and dietary patterns in rural and urban American Indian families with young children.

BACKGROUND: High food insecurity has been demonstrated in rural American Indian households, but little is known about American Indian families in urban settings or the association of food insecurity with diet for these families. The purpose of this study was to examine the prevalence of food insecurity in American Indian households by urban-rural status, correlates of food insecurity in these households, and the relationship between food insecurity and diet in these households. METHODS: Dyads consisting of an adult caregiver and a child (2-5 years old) from the same household in five urban and rural American Indian communities were included. Demographic information was collected, and food insecurity was assessed using two validated items from the USDA Household Food Security Survey. Factors associated with food insecurity were examined using logistic regression. Child and adult diets were assessed using food screeners. Coping strategies were assessed through focus group discussions. These cross-sectional baseline data were collected from 2/2013 through 4/2015 for the Healthy Children, Strong Families 2 randomized controlled trial of a healthy lifestyles intervention for American Indian families. RESULTS: A high prevalence of food insecurity was determined (61%) and was associated with American Indian ethnicity, lower educational level, single adult households, WIC participation, and urban settings (p = 0.05). Food insecure adults had significantly lower intake of vegetables (p < 0.05) and higher intakes of fruit juice (<0.001), other sugar-sweetened beverages (p < 0.05), and fried potatoes (p < 0.001) than food secure adults. Food insecure children had significantly higher intakes of fried potatoes (p < 0.05), soda (p = 0.01), and sports drinks (p < 0.05). Focus group participants indicated different strategies were used by urban and rural households to address food insecurity. CONCLUSIONS: The prevalence of food insecurity in American Indian households in our sample is extremely high, and geographic designation may be an important contributing factor. Moreover, food insecurity had a significant negative influence on dietary intake for families. Understanding strategies employed by households may help inform future interventions to address food insecurity. TRIAL REGISTRATION: ( NCT01776255 ). Registered: January 16, 2013. Date of enrollment: February 6, 2013.

Healthy Children, Strong Families 2: A randomized controlled trial of a healthy lifestyle intervention for American Indian families designed using community-based approaches.

Background/Aims Few obesity prevention trials have focused on young children and their families in the home environment, particularly in underserved communities. Healthy Children, Strong Families 2 is a randomized controlled trial of a healthy lifestyle intervention for American Indian children and their families, a group at very high risk of obesity. The study design resulted from our long-standing engagement with American Indian communities, and few collaborations of this type resulting in the development and implementation of a randomized clinical trial have been described. Methods Healthy Children, Strong Families 2 is a lifestyle intervention targeting increased fruit and vegetable intake, decreased sugar intake, increased physical activity, decreased TV/screen time, and two less-studied risk factors: stress and sleep. Families with young children from five American Indian communities nationwide were randomly assigned to a healthy lifestyle intervention ( Wellness Journey) augmented with social support (Facebook and text messaging) or a child safety control group ( Safety Journey) for 1 year. After Year 1, families in the Safety Journey receive the Wellness Journey, and families in the Wellness Journey start the Safety Journey with continued wellness-focused social support based on communities' request that all families receive the intervention. Primary (adult body mass index and child body mass index z-score) and secondary (health behaviors) outcomes are assessed after Year 1 with additional analyses planned after Year 2. Results To date, 450 adult/child dyads have been enrolled (100% target enrollment). Statistical analyses await trial completion in 2017. Lessons learned Conducting a community-partnered randomized controlled trial requires significant formative work, relationship building, and ongoing flexibility. At the communities' request, the study involved minimal exclusion criteria, focused on wellness rather than obesity, and included an active control group and a design allowing all families to receive the intervention. This collective effort took additional time but was critical to secure community engagement. Hiring and retaining qualified local site coordinators was a challenge but was strongly related to successful recruitment and retention of study families. Local infrastructure has also been critical to project success. Other challenges included geographic dispersion of study communities and providing appropriate incentives to retain families in a 2-year study. Conclusion This multisite intervention addresses key gaps regarding family/home-based approaches for obesity prevention in American Indian communities. Healthy Children, Strong Families 2's innovative aspects include substantial community input, inclusion of both traditional (diet/activity) and less-studied obesity risk factors (stress/sleep), measurement of both adult and child outcomes, social networking support for geographically dispersed households, and a community selected active control group. Our data will address a literature gap regarding multiple risk factors and their relationship to health outcomes in American Indian families.

Development of a Culturally Informed Child Safety Curriculum for American Indian Families.

American Indian (AI) children are disproportionately affected by unintentional injuries, with injury mortality rates approximately 2.3 times higher than the combined rates for all children in the United States. Although multiple risk factors are known to contribute to these increased rates, a comprehensive, culturally informed curriculum that emphasizes child safety is lacking for this population. In response to this need, academic and tribal researchers, tribal community members, tribal wellness staff, and national child safety experts collaborated to develop a novel child safety curriculum. This paper describes its development and community delivery. We developed the safety curriculum as part of a larger randomized controlled trial known as Healthy Children, Strong Families 2 (HCSF2), a family-based intervention targeting obesity prevention in early childhood (2-5 years). During the development of the HCSF2 intervention, participating tribal communities expressed concern about randomizing enrolled families to a control group who would not receive an intervention. To address this concern and the significant disparities in injuries and unintentional death rates among AI children, we added an active control group (Safety Journey) that would utilize our safety curriculum. Satisfaction surveys administered at the 12-month time point of the intervention indicate 94% of participants (N = 196) were either satisfied or very satisfied with the child safety curriculum. The majority of participants (69%) reported spending more than 15 min with the curriculum materials each month, and 83% thought the child safety newsletters were either helpful or very helpful in making changes to improve their family's safety. These findings indicate these child safety materials have been well received by HCSF2 participants. The use of community-engaged approaches to develop this curriculum represents a model that could be adapted for other at-risk populations and serves as an initial step toward the creation of a multi-level child safety intervention strategy.

The Healthy Children, Strong Families intervention promotes improvements in nutrition, activity and body weight in American Indian families with young children.

OBJECTIVE: American Indian children of pre-school age have disproportionally high obesity rates and consequent risk for related diseases. Healthy Children, Strong Families was a family-based randomized trial assessing the efficacy of an obesity prevention toolkit delivered by a mentor v. mailed delivery that was designed and administered using community-based participatory research approaches. DESIGN: During Year 1, twelve healthy behaviour toolkit lessons were delivered by either a community-based home mentor or monthly mailings. Primary outcomes were child BMI percentile, child BMI Z-score and adult BMI. Secondary outcomes included fruit/vegetable consumption, sugar consumption, television watching, physical activity, adult health-related self-efficacy and perceived health status. During a maintenance year, home-mentored families had access to monthly support groups and all families received monthly newsletters. SETTING: Family homes in four tribal communities, Wisconsin, USA. SUBJECTS: Adult and child (2-5-year-olds) dyads (n 150). RESULTS: No significant effect of the mentored v. mailed intervention delivery was found; however, significant improvements were noted in both groups exposed to the toolkit. Obese child participants showed a reduction in BMI percentile at Year 1 that continued through Year 2 (P<0·05); no change in adult BMI was observed. Child fruit/vegetable consumption increased (P=0·006) and mean television watching decreased for children (P=0·05) and adults (P=0·002). Reported adult self-efficacy for health-related behaviour changes (P=0·006) and quality of life increased (P=0·02). CONCLUSIONS: Although no effect of delivery method was demonstrated, toolkit exposure positively affected adult and child health. The intervention was well received by community partners; a more comprehensive intervention is currently underway based on these findings.

The Healthy Children, Strong Families intervention: design and community participation.

Healthy Children, Strong Families (HCSF) is a 2-year, community-driven, family-based randomized controlled trial of a healthy lifestyles intervention conducted in partnership with four Wisconsin American Indian tribes. HCSF is composed of 1 year of targeted home visits to deliver nutritional and physical activity curricula. During Year 1, trained community mentors work with 2-5-year-old American Indian children and their primary caregivers to promote goal-based behavior change. During Year 2, intervention families receive monthly newsletters and attend monthly group meetings to participate in activities designed to reinforce and sustain changes made in Year 1. Control families receive only curricula materials during Year 1 and monthly newsletters during Year 2. Each of the two arms of the study comprises 60 families. Primary outcomes are decreased child body mass index (BMI) z-score and decreased primary caregiver BMI. Secondary outcomes include: increased fruit/vegetable consumption, decreased TV viewing, increased physical activity, decreased soda/sweetened drink consumption, improved primary caregiver biochemical indices, and increased primary caregiver self-efficacy to adopt healthy behaviors. Using community-based participatory research and our history of university-tribal partnerships, the community and academic researchers jointly designed this randomized trial. This article describes the study design and data collection strategies, including outcome measures, with emphasis on the communities' input in all aspects of the research.

Dietary intakes and physical activity among preschool-aged children living in rural American Indian communities before a family-based healthy lifestyle intervention.

OBJECTIVE: To report dietary intake and physical activity among preschool-aged children living in rural American Indian communities before participation in a family-based healthy lifestyle intervention and to compare data to current age-specific recommendations. SUBJECTS/DESIGN: One hundred thirty-five preschool-aged children, living in rural American Indian communities, provided diet and physical activity data before participating in a 2-year randomized healthy lifestyle intervention. Three 24-hour dietary recalls assessed nutrient and food and added sugar intake, which were compared to the National Academy of Science's Dietary Reference Intakes, the US Department of Agriculture's MyPyramid, and American Heart Association recommendations. Time watching television and moderate plus vigorous activity was compared to MyPyramid and American Academy of Pediatrics recommendations. STATISTICAL ANALYSIS: Nutrient, food group, added sugar intake, and time watching television and in moderate or vigorous activity were compared to recommendations by computing the percent of recommendations met. Nonparametric tests identified differences in diet and physical activity among age groups and normal and overweight children (body mass index <85th and > or = 85th percentile). RESULTS: Average nutrient intakes met recommendations whereas food group intakes did not. Mean fruit and vegetable intakes for 2- to 3-year-olds were 0.36 c/day fruit and 0.45 c/day vegetables and, for 4- to 5-year-olds, 0.33 c/day fruit and 0.48 c/day vegetables. Both age groups reported consuming more than 50 g added sugar, exceeding the recommendation of 16 g. Overweight vs normal weight children reported significantly more sweetened beverage intake (8.0+/-0.10 vs 5.28+/-0.08 oz/day, P<0.01). On average, all children reported watching television 2.0 hours/day and significant differences were observed for total television viewing and nonviewing time between overweight and normal weight children (8.52+/-0.6 vs 6.54+/-0.6 hours/day, P<0.01). All children engaged in <20 minutes/day of moderate or vigorous activity. CONCLUSIONS: Overall, children in this sample did not meet MyPyramid recommendations for fruits or vegetables and exceed added sugar intake recommendations. Television viewing time and time when the television was on in the home was highly prevalent along with low levels of moderate or vigorous activity. The Healthy Children Strong Families intervention we studied has potential for improving nutrition and physical activity among preschool-aged children living in rural American Indian communities.

Development of a culturally appropriate, home-based nutrition and physical activity curriculum for Wisconsin American Indian families.

We designed an obesity prevention intervention for American Indian families called Healthy Children, Strong Families using a participatory approach involving three Wisconsin tribes. Healthy Children, Strong Families promotes healthy eating and physical activity for preschool children and their caregivers while respecting each community's cultural and structural framework. Academic researchers, tribal wellness staff, and American Indian community mentors participated in development of the Healthy Children, Strong Families educational curriculum. The curriculum is based on social cognitive and family systems theories as well as on community eating and activity patterns with adaptation to American Indian cultural values. The curricular materials, which were delivered through a home-based mentoring model, have been successfully received and are being modified so that they can be tailored to individual family needs. The curriculum can serve as a nutrition and physical activity model for health educators that can be adapted for other American Indian preschool children and their families or as a model for development of a culturally specific curriculum.