Behavioral CVD Prevention Using Informatics

Health Behavior Clinical Trial

Official title:

Behavioral Cardiovascular Disease Prevention Using Informatics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752464
• Other study ID #: H-34964
• Secondary ID: 14SDG20050015
• Status: Completed
• Phase: N/A
• Start date: September 14, 2016
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2018
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• Counseling
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.
• feedback 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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight-objective measurement	Weight in pounds will be measured objectively with a digital scale	12 weeks
Secondary	Diet, fruits and vegetables, self-reported via questionnaire	Servings of fruits and vegetables will be measured via the Primescreen dietary screener instrument	12 weeks
Secondary	Diet, sugar sweetened beverages, self-reported via questionnaire	Fluid ounces of sugar sweetened beverages will be measured via the BEV-Q questionnaire	12 weeks
Secondary	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
Secondary	Physical activity, objectively measured	Minutes of light to moderate physical activity will be measured via accelerometers (Actigraphs)	12 weeks
Secondary	Physical activity, self-reported	Minutes of light to moderate physical activity will be measured via a questionnaire (IPAQ)	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Social support, self-reported via questionnaire	Perceptions of social support from a variety of sources will be measured via a brief questionnaire	12 weeks
Secondary	Feasibility, number of counseling sessions completed	Number of counseling sessions completed in-person and over the phone will be tallied and reported	12 weeks
Secondary	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