Clinical trial NCT02752464: Behavioral CVD Prevention Using Informatics
Official title: Behavioral Cardiovascular Disease Prevention Using Informatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Weight Loss
Health Status Disparities
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2016-04-27
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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?


Eligibility criteria: 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

Primary outcomes:
measure: Weight-objective measurement
timeFrame: 12 weeks
Secondary outcomes:
measure: Diet, fruits and vegetables, self-reported via questionnaire
timeFrame: 12 weeks
measure: Diet, sugar sweetened beverages, self-reported via questionnaire
timeFrame: 12 weeks
measure: Diet, fast food, self-reported via questionnaire
timeFrame: 12 weeks
measure: Physical activity, objectively measured
timeFrame: 12 weeks
measure: Physical activity, self-reported
timeFrame: 12 weeks
measure: Internal motivation, self-reported via questionnaire
timeFrame: 12 weeks
measure: Self-efficacy for eating a healthful diet, self-reported via questionnaire
timeFrame: 12 weeks
measure: Self-efficacy for doing physical activity, self-reported via questionnaire
timeFrame: 12 weeks
measure: Social support, self-reported via questionnaire
timeFrame: 12 weeks
measure: Feasibility, number of counseling sessions completed
timeFrame: 12 weeks
measure: Feasibility, acceptability of intervention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Lisa M Quintiliani, PhD
role: PRINCIPAL_INVESTIGATOR
References: