OverweightNCT01402557
Telehealth for Weight Maintenance of African-American Women ("Exercise Your Faith")
A study testing Weight Loss Church Program, Telephone Counseling and Telehealth Support in people with Overweight and Obesity, run by University of Illinois Chicago.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Weight Loss Church Program, Telephone Counseling and Telehealth Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Telehealth for Weight Maintenance of African-American Women
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.
Read the detailed description
Rates of obesity in the United States have increased dramatically over the past four decades. Although research studies have demonstrated that weight loss is achievable through lifestyle modifications, the maintenance of weight reduction beyond six months remains a challenge.
This study will examine the feasibility of a telehealth program for weight maintenance. Telehealth is the delivery of health related services to promote healthy behaviors through the innovative use of technology, without the need for travel. The telehealth program will be accessible at home through Internet-enabled television sets. The telehealth program includes three components: (1) weekly video programs that discuss problem solving and relapse prevention strategies and include motivational stories; (2) regularly updated video exercise programs; and (3) online communication with other study participants and an exercise and nutrition specialist.
A randomized controlled trial will determine the feasibility and acceptability of the weight maintenance telehealth program. The study participants will be African-American women, as they have a higher prevalence of obesity with a disproportionate risk of related chronic diseases (e.g., diabetes). Two churches will collaborate with the University of Illinois at Chicago and assist in meeting the social, spiritual, and cultural needs of the participants. One hundred women will be recruited to participate in a one-year trial. The study includes a weight loss phase (Phase 1), and a weight maintenance phase (Phase 2). During Phase 1, all participants will attend a 12-week weight loss program held in the participating churches. Following completion of this program, one church will be assigned to be the intervention group, and the other church will be the comparison group. During Phase 2, participants in the intervention group will receive monthly telephone counseling plus access to the telehealth program, while the comparison group will only receive monthly telephone counseling. The specific aims of the study include: (1) to evaluate the effect of the telehealth program on change in body mass index; and (2) to evaluate the effect of the telehealth program on physical activity and fat, fiber, fruit and vegetable intake.
- Conditions
- Overweight, Obesity
- Being tested
- Weight Loss Church Program, Telephone Counseling, Telehealth Support
- Keywords
- Obesity, Body Weight Changes, Internet
- Medical subject headings
- Overweight, Obesity, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss Church ProgramBehavioural
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.
Telephone CounselingBehavioural
Following completion of the weight loss program, participants will receive monthly telephone counseling.
Telehealth SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telephone Support Only | Active comparator | These participants receive telephone support only during the weight maintenance phase. Receives: Behavioral: Weight Loss Church Program; Behavioral: 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. Receives: Behavioral: Weight Loss Church Program; Behavioral: Telephone Counseling; Behavioral: Telehealth Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Measured: 12 months
Secondary outcomes (2)
Physical activity
Measured: 12 months
Dietary intake
Dietary intake includes fat, fiber, fruits and vegetables.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startAug 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Gerber, University of Illinois Chicago
- Investigators
- Ben Gerber, MD, MPH, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402557
- Sponsor's protocol ID
- 2006-0836
- Other IDs
- R21DK078352
- Status last verified
- Dec 2016
- First submitted
- 25 Jul 2011
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24163236
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth for Weight Maintenance of African-American Women
- ClinicalTrials.gov ID
- NCT01402557
- Acronym / sponsor ID
- 2006-0836
- Conditions
- Overweight, Obesity
- Keywords
- Obesity, Body Weight Changes, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rates of obesity in the United States have increased dramatically over the past four decades. Although research studies have demonstrated that weight loss is achievable through lifestyle modifications, the maintenance of weight reduction beyond six months remains a challenge.
This study will examine the feasibility of a telehealth program for weight maintenance. Telehealth is the delivery of health related services to promote healthy behaviors through the innovative use of technology, without the need for travel. The telehealth program will be accessible at home through Internet-enabled television sets. The telehealth program includes three components: (1) weekly video programs that discuss problem solving and relapse prevention strategies and include motivational stories; (2) regularly updated video exercise programs; and (3) online communication with other study participants and an exercise and nutrition specialist.
A randomized controlled trial will determine the feasibility and acceptability of the weight maintenance telehealth program. The study participants will be African-American women, as they have a higher prevalence of obesity with a disproportionate risk of related chronic diseases (e.g., diabetes). Two churches will collaborate with the University of Illinois at Chicago and assist in meeting the social, spiritual, and cultural needs of the participants. One hundred women will be recruited to participate in a one-year trial. The study includes a weight loss phase (Phase 1), and a weight maintenance phase (Phase 2). During Phase 1, all participants will attend a 12-week weight loss program held in the participating churches. Following completion of this program, one church will be assigned to be the intervention group, and the other church will be the comparison group. During Phase 2, participants in the intervention group will receive monthly telephone counseling plus access to the telehealth program, while the comparison group will only receive monthly telephone counseling. The specific aims of the study include: (1) to evaluate the effect of the telehealth program on change in body mass index; and (2) to evaluate the effect of the telehealth program on physical activity and fat, fiber, fruit and vegetable intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Support Only | Active comparator | Behavioral: Weight Loss Church Program, Behavioral: Telephone CounselingThese participants receive telephone support only during the weight maintenance phase. |
| Telehealth | Experimental | Behavioral: Weight Loss Church Program, Behavioral: Telephone Counseling, Behavioral: Telehealth SupportThese participants receive telehealth support (with Internet-enabled digital video recorders) during the weight maintenance phase. These participants also receive telephone support monthly. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight Loss Church ProgramAn 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. | Behavioural | Telehealth, Telephone Support Only |
| Telephone CounselingFollowing completion of the weight loss program, participants will receive monthly telephone counseling. | Behavioural | Telehealth, Telephone Support Only |
| Telehealth SupportAfter 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. | Behavioural | Telehealth |
Primary outcome
Body mass index
Time frame: 12 months
2 secondary outcomes
Physical activity
Time frame: 12 months
Dietary intake
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Results publication: PubMed 24163236Gerber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Gerber, MD, MPH principal investigator
University of Illinois Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss Church Program, Telephone Counseling and Telehealth Support in people with Overweight and Obesity, run by University of Illinois Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01402557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.