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Completed

NCT Number: NCT02752464

Behavioral CVD 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?

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Key information

Conditions

Health Behavior Behavior Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling

Behavioral

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

Behavioral

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

Primary outcomes

  1. Weight-objective measurement

    Time frame: 12 weeks

    Weight in pounds will be measured objectively with a digital scale

Secondary outcomes

  1. Diet, fruits and vegetables, self-reported via questionnaire

    Time frame: 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

    Time frame: 12 weeks

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

  3. Diet, fast food, self-reported via questionnaire

    Time frame: 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

    Time frame: 12 weeks

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

  5. Physical activity, self-reported

    Time frame: 12 weeks

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

  6. Internal motivation, self-reported via questionnaire

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 12 weeks

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

  11. Feasibility, acceptability of intervention

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Behavioral Cardiovascular Disease Prevention Using Informatics

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 27, 2016
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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