Behavioral CVD Prevention Using Informatics

Study Overview
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Brief Summary
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Overweight/obesity is strongly linked to mortality from multiple chronic diseases, including cardiovascular disease, diabetes, and obesity-related cancers.The successful management of overweight/obesity requires management of nutrition and physical activity over time. For racial/ethnic minority and low-income populations, who face both higher prevalence of obesity and chronic diseases compared to others, interventions promoting behavioral change are a national health priority. From the available range of behavioral change intervention strategies, there is a growing knowledge base that documents the efficacy of peer support interventions for improving self-care, quality of life, and behavioral change. In this study, the investigators will examine the following research question: What is the preliminary efficacy and degree of implementation and acceptability of an intervention approach in which peer counselors provide evidenced-based counseling about nutrition and physical activity behaviors for weight management to public housing residents using a computer-assisted program called CuesWeight?

Official Title
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Behavioral Cardiovascular Disease Prevention Using Informatics

Conditions
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Health Behavior

Intervention / Treatment
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* Behavioral: Counseling
* Behavioral: feedback report


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to wear an accelerometer 18-65 years old Public housing resident with no plans to move in next 6 months Body mass index ≥25 Open to making changes to diet & physical activity habits Exclusion Criteria: Currently enrolled in a comprehensive weight loss program or a research study whose primary outcome is weight loss Primary language spoken is a language other than Spanish or English Not willing to participate in study protocols, including wearing the accelerometer, not willing to have study staff send text messages

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feedback report plus peer counseling<br>Feedback report plus peer counseling Participants receive 12 sessions of behavioral counseling and a brief printed feedback report | Behavioral: Counseling<br>* Up to 12 sessions of behavioral counseling using motivational interviewing techniques focused on diet and physical activity behaviors over a 12 week period. Counselors will be guided in their sessions by a computer program called CuesWeight. Participants also receive text messages to enable participants to track their behaviors; this information is relayed to the counselors to inform the counseling sessions.<br>Behavioral: feedback report<br>* All participants receive a brief printed feedback report displaying their current levels of nutrition and physical activity behaviors and tips for meeting recommended guidelines.<br>|
| Active Comparator: Feedback report<br>Feedback report Participants receive a brief printed feedback report | Behavioral: feedback report<br>* All participants receive a brief printed feedback report displaying their current levels of nutrition and physical activity behaviors and tips for meeting recommended guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight-objective measurement | Weight in pounds will be measured objectively with a digital scale | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet, fruits and vegetables, self-reported via questionnaire | Servings of fruits and vegetables will be measured via the Primescreen dietary screener instrument | 12 weeks | 
| Diet, sugar sweetened beverages, self-reported via questionnaire | Fluid ounces of sugar sweetened beverages will be measured via the BEV-Q questionnaire | 12 weeks | 
| Diet, fast food, self-reported via questionnaire | Number of visits to fast food restaurants will be measured via a 1-item question asking participants how often they go to fast food restaurants | 12 weeks | 
| Physical activity, objectively measured | Minutes of light to moderate physical activity will be measured via accelerometers (Actigraphs) | 12 weeks | 
| Physical activity, self-reported | Minutes of light to moderate physical activity will be measured via a questionnaire (IPAQ) | 12 weeks | 
| Internal motivation, self-reported via questionnaire | Perceptions of internal motivation to change diet and physical activity will be measured by a brief questionnaire | 12 weeks | 
| Self-efficacy for eating a healthful diet, self-reported via questionnaire | Perceptions of self-efficacy (or confidence) to change diet behaviors in a variety of situations will be measured by a brief questionnaire | 12 weeks | 
| Self-efficacy for doing physical activity, self-reported via questionnaire | Perceptions of self-efficacy (or confidence) to change physical activity behaviors in a variety of situations will be measured by a brief questionnaire | 12 weeks | 
| Social support, self-reported via questionnaire | Perceptions of social support from a variety of sources will be measured via a brief questionnaire | 12 weeks | 
| Feasibility, number of counseling sessions completed | Number of counseling sessions completed in-person and over the phone will be tallied and reported | 12 weeks | 
| Feasibility, acceptability of intervention | Perceptions of acceptability of both the brief feedback report and the counseling sessions will be asked in open- and closed-ended questions | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, Health Status Disparities