OverweightNCT01282749
Effectiveness of SisterTalk Hartford for Weight Loss Among African-American Women
A study testing SisterTalk Hartford in people with Overweight and Obesity, run by UConn Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- SisterTalk Hartford
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Aug 2006
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: 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.
- Conditions
- Overweight, Obesity
- Being tested
- SisterTalk Hartford, Attention control video series
- Keywords
- Overweight, Obesity, African American, Women, Translational, Faith based, Community based participatory research
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SisterTalk HartfordBehavioural
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.
Attention control video seriesBehavioural
Participants received general film series on healthy lifestyles while waiting to participate in the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| SisterTalk Hartford First | Experimental | 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. Receives: Behavioral: SisterTalk Hartford |
| SisterTalk Hartford Second | Other | Participants received general film series on healthy lifestyles while waiting to participate in the experimental arm. Receives: Behavioral: Attention control video series |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Change in BMI
Measured: assessed 4 times over 2 years, in roughly 6 mo intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startOct 2002
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- St. Francis Hospital & Medical Center, Hartford CT, Brown University
- Responsible party
- Sponsor
- Investigators
- Judith Fifield, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282749
- Sponsor's protocol ID
- O02-07-003-E
- Other IDs
- SR0550
- Status last verified
- Nov 2023
- First submitted
- 21 Jan 2011
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hospitals-Churches Partnership for Health Project: SisterTalk Hartford
- ClinicalTrials.gov ID
- NCT01282749
- Acronym / sponsor ID
- O02-07-003-E
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, African American, Women, Translational, Faith based, Community based participatory research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- St. Francis Hospital & Medical Center, Hartford CT, Brown University
- Study start
- Oct 2002
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 25 Jan 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SisterTalk Hartford First | Experimental | Behavioral: SisterTalk Hartford12-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. |
| SisterTalk Hartford Second | Other | Behavioral: Attention control video seriesParticipants received general film series on healthy lifestyles while waiting to participate in the experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| SisterTalk Hartford12-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. | Behavioural | SisterTalk Hartford First |
| Attention control video seriesParticipants received general film series on healthy lifestyles while waiting to participate in the experimental arm. | Behavioural | SisterTalk Hartford Second |
Primary outcome
weight loss
Time frame: assessed 4 times over 2 years, in roughly 6 mo intervals
Change in BMI
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 Nov 2023.
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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.
Judith Fifield, PhD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SisterTalk Hartford in people with Overweight and Obesity, run by UConn Health at 1 site in United States.
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 3 inclusion and 9 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 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
weight loss (time frame: assessed 4 times over 2 years, in roughly 6 mo intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2023.