NCT02752464

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 14, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

1.7 years

First QC Date

April 19, 2016

Last Update Submit

June 29, 2018

Conditions

Health Behavior

Keywords

Weight LossHealth Status Disparities

Outcome Measures

Primary Outcomes (1)

  • Weight-objective measurement

    Weight in pounds will be measured objectively with a digital scale

    12 weeks

Secondary Outcomes (11)

  • 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

  • Physical activity, objectively measured

    12 weeks

  • Physical activity, self-reported

    12 weeks

  • +6 more secondary outcomes

Study Arms (2)

Feedback report plus peer counseling

EXPERIMENTAL

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

Behavioral: CounselingBehavioral: feedback report

Feedback report

ACTIVE COMPARATOR

Feedback report Participants receive a brief printed feedback report

Behavioral: feedback report

Interventions

CounselingBEHAVIORAL

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 plus peer counseling
feedback reportBEHAVIORAL

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 reportFeedback report plus peer counseling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to wear an accelerometer
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Health BehaviorWeight Loss

Interventions

Counseling

Condition Hierarchy (Ancestors)

BehaviorBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lisa M Quintiliani, PhD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 27, 2016

Study Start

September 14, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 2, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)