Behavioral CVD Prevention Using Informatics

Sponsor
Boston Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02752464
Collaborator
American Heart Association (Other)
105
1
2
20.5
5.1

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Counseling
  • Behavioral: feedback report
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Behavioral Cardiovascular Disease Prevention Using Informatics
Actual Study Start Date :
Sep 14, 2016
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Weight-objective measurement [12 weeks]

    Weight in pounds will be measured objectively with a digital scale

Secondary Outcome Measures

  1. Diet, fruits and vegetables, self-reported via questionnaire [12 weeks]

    Servings of fruits and vegetables will be measured via the Primescreen dietary screener instrument

  2. Diet, sugar sweetened beverages, self-reported via questionnaire [12 weeks]

    Fluid ounces of sugar sweetened beverages will be measured via the BEV-Q questionnaire

  3. Diet, fast food, self-reported via questionnaire [12 weeks]

    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

  4. Physical activity, objectively measured [12 weeks]

    Minutes of light to moderate physical activity will be measured via accelerometers (Actigraphs)

  5. Physical activity, self-reported [12 weeks]

    Minutes of light to moderate physical activity will be measured via a questionnaire (IPAQ)

  6. Internal motivation, self-reported via questionnaire [12 weeks]

    Perceptions of internal motivation to change diet and physical activity will be measured by a brief questionnaire

  7. Self-efficacy for eating a healthful diet, self-reported via questionnaire [12 weeks]

    Perceptions of self-efficacy (or confidence) to change diet behaviors in a variety of situations will be measured by a brief questionnaire

  8. Self-efficacy for doing physical activity, self-reported via questionnaire [12 weeks]

    Perceptions of self-efficacy (or confidence) to change physical activity behaviors in a variety of situations will be measured by a brief questionnaire

  9. Social support, self-reported via questionnaire [12 weeks]

    Perceptions of social support from a variety of sources will be measured via a brief questionnaire

  10. Feasibility, number of counseling sessions completed [12 weeks]

    Number of counseling sessions completed in-person and over the phone will be tallied and reported

  11. Feasibility, acceptability of intervention [12 weeks]

    Perceptions of acceptability of both the brief feedback report and the counseling sessions will be asked in open- and closed-ended questions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston Medical Center Boston Massachusetts United States 02118

Sponsors and Collaborators

  • Boston Medical Center
  • American Heart Association

Investigators

  • Principal Investigator: Lisa M Quintiliani, PhD, Boston Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lisa M. Quintiliani, Assistant Professor, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT02752464
Other Study ID Numbers:
  • H-34964
  • 14SDG20050015
First Posted:
Apr 27, 2016
Last Update Posted:
Jul 2, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lisa M. Quintiliani, Assistant Professor, Boston Medical Center

Study Results

No Results Posted as of Jul 2, 2018