Using targeting to recruit men and women of color into a behavioral weight loss trial.

BACKGROUND: The majority of participants in weight loss trials are non-Hispanic White women, while men and women of color are underrepresented. This study presents data obtained from non-targeted and targeted recruitment approaches in a trial of behavioral weight loss programs to (1) describe the yields from each approach and (2) compare the demographics, weight control histories, and study involvement of samples recruited by each approach. METHODS: Data for this observational study include source of recruitment, demographic information, weight loss experiences (e.g., lifetime weight loss, current weight loss behaviors), and completion of the 6-month assessment visit. RESULTS: Men comprised 14.2% of participants who responded to non-targeted recruitment efforts, while targeted efforts yielded 50.4% men. Similarly, people of color comprised 12.8% of those who responded to non-targeted approaches, whereas targeted recruitment methods yielded 47.2% people of color. Men recruited through targeted methods were younger (p = 0.01) than men recruited through non-targeted means but were otherwise similar. Women of color recruited through targeted methods reported use of fewer weight loss strategies relative to women of color recruited through non-targeted means (p = 0.006) but were otherwise similar. There were no differences by recruitment method on retention to the study. CONCLUSIONS: Using targeted recruitment methods increased the ethnic and gender diversity of the recruited sample without reducing study retention. This targeting also increased the enrollment of women with less weight loss experience who may not have otherwise sought out a weight loss program. Developing and implementing a targeted recruitment plan should be considered early in the clinical trial development process. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02368002. Registered on 20 February 2015.

Psychosocial mechanisms for the transmission of somatic symptoms from parents to children.

AIM: To examine familial aggregation of irritable bowel syndrome (IBS) via parental reinforcement/modeling of symptoms, coping, psychological distress, and exposure to stress. METHODS: Mothers of children between the ages of 8 and 15 years with and without IBS were identified through the Group Health Cooperative of Puget Sound. Mothers completed questionnaires, including the Child Behavior Checklist (child psychological distress), the Family Inventory of Life Events (family exposure to stress), SCL-90R (mother psychological distress), and the Pain Response Inventory (beliefs about pain). Children were interviewed separately from their parents and completed the Pain Beliefs Questionnaire (beliefs about pain), Pain Response Inventory (coping) and Child Symptom Checklist [gastrointestinal (GI) symptoms]. In addition, health care utilization data was obtained from the automated database of Group Health Cooperative. Mothers with IBS (n = 207) and their 296 children were compared to 240 control mothers and their 335 children, while controlling for age and education. RESULTS: Hypothesis 1: reinforcement of expression of GI problems is only related to GI symptoms, but not others (cold symptoms) in children. There was no significant correlation between parental reinforcement of symptoms and child expression of GI or other symptoms. Hypothesis 2: modeling of GI symptoms is related to GI but not non-GI symptom reporting in children. Children of parents with IBS reported more non-GI (8.97 vs 6.70, P < 0.01) as well as more GI (3.24 vs 2.27, P < 0.01) symptoms. Total health care visits made by the mother correlated with visits made by the child (rho = 0.35, P < 0.001 for cases, rho = 0.26, P < 0.001 for controls). Hypothesis 3: children learn to share the methods of coping with illness that their mothers exhibit. Methods used by children to cope with stomachaches differed from methods used by their mothers. Only 2/16 scales showed weak but significant correlations (stoicism rho = 0.13, P < 0.05; acceptance rho = 0.13, P < 0.05). Hypothesis 4: mothers and children share psychological traits such as anxiety, depression, and somatization. Child psychological distress correlated with mother's psychological distress (rho = 0.41, P < 0.001 for cases, rho= 0.38, P < 0.001 for controls). Hypothesis 5: stress that affects the whole family might explain the similarities between mothers and their children. Family exposure to stress was not a significant predictor of children's symptom reports. Hypothesis 6: the intergenerational transmission of GI illness behavior may be due to multiple mechanisms. Regression analysis identified multiple independent predictors of the child's GI complaints, which were similar to the predictors of the child's non-GI symptoms (mother's IBS status, child psychological symptoms, child catastrophizing, and child age). CONCLUSION: Multiple factors influence the reporting of children's gastrointestinal and non-gastrointestinal symptoms. The clustering of illness within families is best understood using a model that incorporates all these factors.

Healthy Homes/Healthy Kids: a randomized trial of a pediatric primary care-based obesity prevention intervention for at-risk 5-10 year olds.

Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to families in the pediatric primary care setting, overcome barriers to implementation in busy practice settings, and facilitate sustained involvement of parents is an important public health priority. The goal of the Healthy Homes/Healthy Kids (HHHK 5-10) randomized controlled trial is to evaluate the efficacy of a relatively low-cost primary care-based obesity prevention intervention aimed at 5 to 10 year old children who are at risk for obesity. Four hundred twenty one parent/child dyads were recruited and randomized to either the obesity prevention arm or a Contact Control condition that focuses on safety and injury prevention. The HHHK 5-10 obesity prevention intervention combines brief counseling with a pediatric primary care provider during routine well child visits and follow-up telephone coaching that supports parents in making home environmental changes to support healthful eating, activity patterns, and body weight. The Contact Control condition combines the same provider counseling with telephone coaching focused on safety and injury prevention messages. This manuscript describes the study design and baseline characteristics of participants enrolled in the HHHK 5-10 trial.

Project həli?dx(w)/Healthy Hearts Across Generations: development and evaluation design of a tribally based cardiovascular disease prevention intervention for American Indian families.

American Indian and Alaska Native (AIAN) populations are disproportionately at risk for cardiovascular disease (CVD), diabetes, and obesity, compared with the general US population. This article describes the həli?dx(w)/Healthy Hearts Across Generations project, an AIAN-run, tribally based randomized controlled trial (January 2010-June 2012) designed to evaluate a culturally appropriate CVD risk prevention program for AI parents residing in the Pacific Northwest of the United States. At-risk AIAN adults (n = 135) were randomly assigned to either a CVD prevention intervention arm or a comparison arm focusing on increasing family cohesiveness, communication, and connectedness. Both year-long conditions included 1 month of motivational interviewing counseling followed by personal coach contacts and family life-skills classes. Blood chemistry, blood pressure, body mass index, food intake, and physical activity were measured at baseline and at 4- and 12-month follow-up times.

Complementary and alternative medicine use and cost in functional bowel disorders: a six month prospective study in a large HMO.

BACKGROUND: Functional Bowel Disorders (FBD) are chronic disorders that are difficult to treat and manage. Many patients and doctors are dissatisfied with the level of improvement in symptoms that can be achieved with standard medical care which may lead them to seek alternatives for care. There are currently no data on the types of Complementary and Alternative Medicine (CAM) used for FBDs other than Irritable Bowel Syndrome (IBS), or on the economic costs of CAM treatments. The aim of this study is to determine prevalence, types and costs of CAM in IBS, functional diarrhea, functional constipation, and functional abdominal pain. METHODS: 1012 Patients with FBD were recruited through a health care maintenance organization and followed for 6 months. Questionnaires were used to ascertain: Utilization and expenditures on CAM, symptom severity (IBS-SS), quality of life (IBS-QoL), psychological distress (BSI) and perceived treatment effectiveness. Costs for conventional medical care were extracted from administrative claims. RESULTS: CAM was used by 35% of patients, at a median yearly cost of $200. The most common CAM types were ginger, massage therapy and yoga. CAM use was associated with female gender, higher education, and anxiety. Satisfaction with physician care and perceived effectiveness of prescription medication were not associated with CAM use. Physician referral to a CAM provider was uncommon but the majority of patients receiving this recommendation followed their physician's advice. CONCLUSION: CAM is used by one-third of FBD patients. CAM use does not seem to be driven by dissatisfaction with conventional care. Physicians should discuss CAM use and effectiveness with their patients and refer patients if appropriate.

Increased colonic pain sensitivity in irritable bowel syndrome is the result of an increased tendency to report pain rather than increased neurosensory sensitivity.

OBJECTIVE: The aim was to determine whether lower visceral pain thresholds in irritable bowel syndrome (IBS) primarily reflect physiological or psychological factors. METHODS: Firstly, 121 IBS patients and 28 controls underwent balloon distensions in the descending colon using the ascending methods of limits (AML) to assess pain and urge thresholds. Secondly, sensory decision theory analysis was used to separate physiological from psychological components of perception: neurosensory sensitivity (p(A)) was measured by the ability to discriminate between 30 mm Hg vs 34 mm Hg distensions; psychological influences were measured by the report criterion-that is, the overall tendency to report pain, indexed by the median intensity rating for all distensions, independent of intensity. Psychological symptoms were assessed using the Brief Symptom Inventory (BSI). RESULTS: IBS patients had lower AML pain thresholds (median: 28 mm Hg vs 40 mm Hg; p<0.001), but similar neurosensory sensitivity (median p(A): 0.5 vs 0.5; p = 0.69; 42.6% vs 42.9% were able to discriminate between the stimuli better than chance) and a greater tendency to report pain (median report criterion: 4.0 ("mild" pain) vs 5.2 ("weak" pain); p = 0.003). AML pain thresholds were not correlated with neurosensory sensitivity (r = -0.13; p = 0.14), but were strongly correlated with report criterion (r = 0.67; p<0.0001). Report criterion was inversely correlated with BSI somatisation (r = -0.26; p = 0.001) and BSI global score (r = -0.18; p = 0.035). Similar results were seen for the non-painful sensation of urgency. CONCLUSION: Increased colonic sensitivity in IBS is strongly influenced by a psychological tendency to report pain and urge rather than increased neurosensory sensitivity.