Behavioral CVD Prevention Using Informatics

Behavioral Cardiovascular Disease Prevention Using Informatics

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?

Study Overview

• Status: Completed
• Conditions: Health Behavior
• Intervention / Treatment: Behavioral: Counseling; Behavioral: feedback report

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feedback report plus peer counseling; Feedback report plus peer counseling Participants receive 12 sessions of behavioral counseling and a brief printed feedback report	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.; Behavioral: 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.
Active Comparator: Feedback report; Feedback report Participants receive a brief printed feedback report	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Lisa M Quintiliani, PhD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 23, 2016
• First Posted (Estimate): April 27, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: June 29, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Weight Loss; Health Status Disparities
• Other Study ID Numbers: H-34964; 14SDG20050015 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No