Back to resultsEffectiveness of SisterTalk Hartford for Weight Loss Among African-American Women
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SisterTalk Hartford
Attention control video series
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity, African American, Women, Translational, Faith based, Community based participatory research
Eligibility Criteria
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)
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
SisterTalk Hartford First
SisterTalk Hartford Second
Arm Description
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.
Participants received general film series on healthy lifestyles while waiting to participate in the experimental arm.
Outcomes
Primary Outcome Measures
weight loss
Change in BMI
Secondary Outcome Measures
Full Information
NCT ID
NCT01282749
First Posted
January 21, 2011
Last Updated
May 27, 2014
Sponsor
UConn Health
Collaborators
St. Francis Hospital & Medical Center, Hartford CT, Brown University
1. Study Identification
Unique Protocol Identification Number
NCT01282749
Brief Title
Effectiveness of SisterTalk Hartford for Weight Loss Among African-American Women
Official Title
The Hospitals-Churches Partnership for Health Project: SisterTalk Hartford
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
St. Francis Hospital & Medical Center, Hartford CT, Brown University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity, African American, Women, Translational, Faith based, Community based participatory research
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
322 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SisterTalk Hartford First
Arm Type
Experimental
Arm Description
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.
Arm Title
SisterTalk Hartford Second
Arm Type
Other
Arm Description
Participants received general film series on healthy lifestyles while waiting to participate in the experimental arm.
Intervention Type
Behavioral
Intervention Name(s)
SisterTalk Hartford
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention control video series
Intervention Description
Participants received general film series on healthy lifestyles while waiting to participate in the experimental arm.
Primary Outcome Measure Information:
Title
weight loss
Description
Change in BMI
Time Frame
assessed 4 times over 2 years, in roughly 6 mo intervals
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Fifield, PhD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of SisterTalk Hartford for Weight Loss Among African-American Women
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