NCT01402557

Brief Summary

Obesity can cause many health problems, including high blood pressure, diabetes, heart disease, and stroke. Although some people may lose weight through diet and exercise, many regain weight over time. There is a need to study new ways of helping people maintain their weight. The purpose of this research is to study the effect of a weight maintenance program provided through home television sets connected to the Internet.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
Last Updated

December 28, 2016

Status Verified

December 1, 2016

Enrollment Period

2.6 years

First QC Date

July 25, 2011

Last Update Submit

December 26, 2016

Conditions

Keywords

ObesityBody Weight ChangesInternet

Outcome Measures

Primary Outcomes (1)

  • Body mass index

    12 months

Secondary Outcomes (2)

  • Physical activity

    12 months

  • Dietary intake

    12 months

Study Arms (2)

Telephone Support Only

ACTIVE COMPARATOR

These participants receive telephone support only during the weight maintenance phase.

Behavioral: Weight Loss Church ProgramBehavioral: Telephone Counseling

Telehealth

EXPERIMENTAL

These participants receive telehealth support (with Internet-enabled digital video recorders) during the weight maintenance phase. These participants also receive telephone support monthly.

Behavioral: Weight Loss Church ProgramBehavioral: Telephone CounselingBehavioral: Telehealth Support

Interventions

An initial 12-week weight loss program held in churches to ensure adequate participation, competence in performing exercises, and development of social relationships among participants. All participants attend the church programs prior to the weight maintenance phase.

TelehealthTelephone Support Only

Following completion of the weight loss program, participants will receive monthly telephone counseling.

TelehealthTelephone Support Only

After the weight loss program, women will access the home weight maintenance telehealth program through Internet enabled digital video recorders connected to their television sets. The telehealth program includes three components: (1) Weekly Video: home access to weekly video programs including problem solving and relapse prevention strategies, as well as motivational stories; (2) Teleexercise: home access to updated video exercise programs; and (3) Electronic Communication: social support through online communication with other participants, and with an exercise and nutrition interventionist.

Telehealth

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identification as an African-American or Black woman
  • Age 35-65 years
  • Body mass index 25-50 kg/m2
  • Physician approval to safely exercise if any positive answers on Physical Activity Readiness Questionnaire
  • Owns a television
  • Has a working telephone line

You may not qualify if:

  • Plans to move from the Chicago area during the coming year
  • Has a household member already in the study
  • Uses illicit drugs or drinks more than two alcoholic drinks daily
  • Pregnant, nursing, or planning pregnancy
  • Participating in an organized weight loss program or using pharmacotherapy for weight loss
  • Use an assistive device for ambulation, or cannot participate in exercise classes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gerber BS, Schiffer L, Brown AA, Berbaum ML, Rimmer JH, Braunschweig CL, Fitzgibbon ML. Video telehealth for weight maintenance of African-American women. J Telemed Telecare. 2013 Jul;19(5):266-72. doi: 10.1177/1357633X13490901. Epub 2013 Jun 14.

MeSH Terms

Conditions

OverweightObesityBody Weight Changes

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ben Gerber, MD, MPH

    University of Illinois at Chicago

    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
Professor of Medicine

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 26, 2011

Study Start

August 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

December 28, 2016

Record last verified: 2016-12