- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01282749
Effectiveness of SisterTalk Hartford for Weight Loss Among African-American Women
November 21, 2023 updated by: UConn Health
The Hospitals-Churches Partnership for Health Project: SisterTalk Hartford
The purpose of the SisterTalk Hartford study was to assess whether a theoretically- and scientifically-based, culturally acceptable weight loss program could be effectively translated into a faith-based program and subsequently delivered in the church to help African-American women lose weight.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
322
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Farmington, Connecticut, United States, 06030
- University of Connecticut Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- BMI of at least 25.0
- self-identifies as Black or African-American
- able to do mild physical activity such as walking or chair exercises
Exclusion Criteria:
- has insulin dependent diabetes
- is pregnant, nursing, or had a baby in the past 4 months
- has ever been treated for an eating disorder (e.g. anorexia nervosa, bulimia)
- had a heart attack in the past 2 years requiring hospitalization
- has ever had a stroke
- has congestive heart failure
- has uncontrolled hypertension
- currently participating in another study
- is on a doctor-prescribed diet that cannot be changed (e.g. very low protein diet for a person in liver failure)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SisterTalk Hartford First
12-week group support and film-based healthy lifestyle education program, including information on healthy nutrition and food preparation, increasing activity and exercise, healthy lifestyle behavior modification, and supportive spiritual materials.
|
12-week group support and film-based healthy lifestyle education program, including information on healthy nutrition and food preparation, increasing activity and exercise, healthy lifestyle behavior modification, and supportive spiritual materials.
|
|
Other: SisterTalk Hartford Second
Participants received general film series on healthy lifestyles while waiting to participate in the experimental arm.
|
Participants received general film series on healthy lifestyles while waiting to participate in the experimental arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
weight loss
Time Frame: assessed 4 times over 2 years, in roughly 6 mo intervals
|
Change in BMI
|
assessed 4 times over 2 years, in roughly 6 mo intervals
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Judith Fifield, PhD, UConn Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
January 21, 2011
First Submitted That Met QC Criteria
January 21, 2011
First Posted (Estimated)
January 25, 2011
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 21, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- O02-07-003-E
- SR0550 (Other Identifier: Saint Francis Hospital)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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