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Clinical Trials/NCT02752464
NCT02752464CompletedNot Applicable

Behavioral Cardiovascular Disease Prevention Using Informatics

Boston Medical Center1 site in 1 country105 target enrollmentStarted: September 14, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
105
Locations
1
Primary Endpoint
Weight-objective measurement

Study Overview

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?

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Feedback report plus peer counseling

Experimental

Feedback report plus peer counseling Participants receive 12 sessions of behavioral counseling and a brief printed feedback report

Intervention: Counseling (Behavioral)

Feedback report plus peer counseling

Experimental

Feedback report plus peer counseling Participants receive 12 sessions of behavioral counseling and a brief printed feedback report

Intervention: feedback report (Behavioral)

Feedback report

Active Comparator

Feedback report Participants receive a brief printed feedback report

Intervention: feedback report (Behavioral)

Outcomes

Primary Outcomes

Weight-objective measurement

Time Frame: 12 weeks

Weight in pounds will be measured objectively with a digital scale

Secondary Outcomes

  • Self-efficacy for doing physical activity, self-reported via questionnaire(12 weeks)
  • Self-efficacy for eating a healthful diet, self-reported via questionnaire(12 weeks)
  • Feasibility, number of counseling sessions completed(12 weeks)
  • Feasibility, acceptability of intervention(12 weeks)
  • Diet, fruits and vegetables, self-reported via questionnaire(12 weeks)
  • Diet, sugar sweetened beverages, self-reported via questionnaire(12 weeks)
  • Diet, fast food, self-reported via questionnaire(12 weeks)
  • Internal motivation, self-reported via questionnaire(12 weeks)
  • Physical activity, objectively measured(12 weeks)
  • Physical activity, self-reported(12 weeks)
  • Social support, self-reported via questionnaire(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lisa M. Quintiliani

Assistant Professor

Boston Medical Center

Study Sites (1)

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