Behavioral CVD Prevention Using Informatics

NCT ID: NCT02752464

Last Updated: 2018-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-14

Study Completion Date

2018-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Health Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Feedback report plus peer counseling

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

Group Type EXPERIMENTAL

Counseling

Intervention Type 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

Intervention Type 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.

Feedback report

Feedback report Participants receive a brief printed feedback report

Group Type ACTIVE_COMPARATOR

feedback report

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

American Heart Association

OTHER

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lisa M. Quintiliani

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lisa M Quintiliani, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14SDG20050015

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-34964

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.