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Behavioral CVD Prevention Using Informatics

Behavioral Cardiovascular Disease Prevention Using Informatics

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02752464
Enrollment
105
Registered
2016-04-27
Start date
2016-09-14
Completion date
2018-06-01
Last updated
2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

Keywords

Weight Loss, Health Status Disparities

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?

Interventions

BEHAVIORALCounseling

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.

BEHAVIORALfeedback report

All participants receive a brief printed feedback report displaying their current levels of nutrition and physical activity behaviors and tips for meeting recommended guidelines.

Sponsors

American Heart Association
CollaboratorOTHER
Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Weight-objective measurement12 weeksWeight in pounds will be measured objectively with a digital scale

Secondary

MeasureTime frameDescription
Diet, fruits and vegetables, self-reported via questionnaire12 weeksServings of fruits and vegetables will be measured via the Primescreen dietary screener instrument
Diet, sugar sweetened beverages, self-reported via questionnaire12 weeksFluid ounces of sugar sweetened beverages will be measured via the BEV-Q questionnaire
Diet, fast food, self-reported via questionnaire12 weeksNumber of visits to fast food restaurants will be measured via a 1-item question asking participants how often they go to fast food restaurants
Physical activity, objectively measured12 weeksMinutes of light to moderate physical activity will be measured via accelerometers (Actigraphs)
Internal motivation, self-reported via questionnaire12 weeksPerceptions of internal motivation to change diet and physical activity will be measured by a brief questionnaire
Physical activity, self-reported12 weeksMinutes of light to moderate physical activity will be measured via a questionnaire (IPAQ)
Self-efficacy for doing physical activity, self-reported via questionnaire12 weeksPerceptions of self-efficacy (or confidence) to change physical activity behaviors in a variety of situations will be measured by a brief questionnaire
Social support, self-reported via questionnaire12 weeksPerceptions of social support from a variety of sources will be measured via a brief questionnaire
Feasibility, number of counseling sessions completed12 weeksNumber of counseling sessions completed in-person and over the phone will be tallied and reported
Feasibility, acceptability of intervention12 weeksPerceptions of acceptability of both the brief feedback report and the counseling sessions will be asked in open- and closed-ended questions
Self-efficacy for eating a healthful diet, self-reported via questionnaire12 weeksPerceptions of self-efficacy (or confidence) to change diet behaviors in a variety of situations will be measured by a brief questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026