ObesityNCT02631018
Sisters in Health: A Weight Loss Study for African American Women
A study testing Standard Weight Loss Intervention and Physical Activity Enhanced Weight Loss Intervention in people with Obesity, run by University of North Carolina, Chapel Hill.
Trial summary
The purpose of this study is to compare the effect of a physical activity-enhanced behavioral weight loss intervention, compared to a standard behavioral weight loss intervention in African American women. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Standard Weight Loss Intervention and Physical Activity Enhanced Weight Loss Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2017
- 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 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21-65 years old
- Ability to read, write, and speak English
- Female gender
- African American/Black/African/Afro-Caribbean race (self-identified)
- BMI 25-45 (> 45 may have greater risks while participating)
- Meets criteria for low active (defined as <3 days/week of at most 20 min. of PA/day) assessed by X
Show all 13Show fewer
- Willingness to be randomized
- Willingness to participate for 6 months, including attending face-to-face sessions \& outside of session tasks
- Access to a computer reliable internet access
- Willingness to use an app for diet and physical activity monitoring
- Regularly used email address
- Not planning to relocate
- Able to attend group sessions on scheduled day
Who cannot join
- Recently lost weight, 5-10% in last 6 months
- Currently participating in another weight loss or PA study, or taking weight loss medication, and unwilling to discontinue those activities
- Pregnant or planning to become pregnant
- Any physical limitations to engaging in or increasing physical activity/exercise- assessed by PAR-Q (including but not limited to heart attack/myocardial infarction, congestive heart failure)
- Type 2 diabetes being treated with insulin
- Major psychological disorder
- History of diagnosed eating disorder
- Medications that affect weight (determined by study staff)
About this study
The purpose of this study is to compare the effect of a physical activity-enhanced behavioral weight loss intervention, compared to a standard behavioral weight loss intervention in African American women.
Read the detailed description
A disparity exists in the prevalence of overweight and obesity between non-Hispanic white (NHW) and African American (AA) women. More AA women (78.2%) are overweight or obese compared to NHW (61.2%). Obesity increases the risk of developing numerous chronic diseases, including type 2 diabetes (T2DM), hypertension, cardiovascular disease, and some cancers. Among AA women, there is a higher prevalence, and almost double the risk, of developing T2DM compared to NHW. African Americans also have higher rates of complications and mortality from T2DM, and are more at risk for hypertension compared to NHW. Obesity is a costly epidemic. Fortunately, weight is a modifiable risk factor for reducing or preventing obesity and related diseases.
Interventions to reduce overweight and obesity through lifestyle change have been less effective for AA women compared to NHW women. African American women tend to lose less weight in standard behavioral weight loss interventions. A potential reason for smaller weight loss is that compared to NHW women, AA women have been shown to engage in less physical activity (PA) during these interventions.
The Sisters in Health study will test the efficacy of a 6-month randomized controlled trial in overweight and obese African American women. Women will be recruited to participate in this study comparing a standard behavioral weight loss intervention (BWI) to a physical activity enhanced BWI (BWI-PA) for 6 months. The primary objective of this study is to determine if AA women randomized to the BWI-PA will experience greater weight loss and PA compared to women receiving the BWI. Women in both groups will receive 18 face-to-face sessions on a tapered basis (weekly to biweekly). Face-to-face sessions will provide women with the knowledge, behavioral skills and strategies for weight loss.
- Conditions
- Obesity
- Being tested
- Standard Weight Loss Intervention, Physical Activity Enhanced Weight Loss Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Weight Loss InterventionBehavioural
18 session, group-based, 6-month, standard behavioral weight loss intervention
Physical Activity Enhanced Weight Loss InterventionBehavioural
18 session, group-based, 6-month, physical activity enhanced behavioral weight loss intervention
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Enhanced Weight Loss Intervention | Experimental | Participants will engage in 18 weight loss intervention group sessions over 6 months. Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months. Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations. This arm, uniquely, will receive a culturally based physical activity component. Receives: Behavioral: Physical Activity Enhanced Weight Loss Intervention |
| Standard Weight Loss Intervention | Active comparator | Participants will engage in 18 weight loss intervention group sessions over 6 months. Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months. Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations. Receives: Behavioral: Standard Weight Loss Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Responsible party
- Principal investigator, Loneke T. Blackman Carr, University of North Carolina, Chapel Hill
- Investigators
- Deborah F. Tate, PhD, Study chair, University of North Carolina, Chapel HillLoneke T. Blackman Carr, MA, RD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631018
- Sponsor's protocol ID
- 15-0484
- Status last verified
- Apr 2017
- First submitted
- 11 Dec 2015
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sisters in Health: A Weight Loss Study for African American Women
- ClinicalTrials.gov ID
- NCT02631018
- Acronym / sponsor ID
- 15-0484
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 Dec 2015 (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 this study is to compare the effect of a physical activity-enhanced behavioral weight loss intervention, compared to a standard behavioral weight loss intervention in African American women.
Detailed description
A disparity exists in the prevalence of overweight and obesity between non-Hispanic white (NHW) and African American (AA) women. More AA women (78.2%) are overweight or obese compared to NHW (61.2%). Obesity increases the risk of developing numerous chronic diseases, including type 2 diabetes (T2DM), hypertension, cardiovascular disease, and some cancers. Among AA women, there is a higher prevalence, and almost double the risk, of developing T2DM compared to NHW. African Americans also have higher rates of complications and mortality from T2DM, and are more at risk for hypertension compared to NHW. Obesity is a costly epidemic. Fortunately, weight is a modifiable risk factor for reducing or preventing obesity and related diseases.
Interventions to reduce overweight and obesity through lifestyle change have been less effective for AA women compared to NHW women. African American women tend to lose less weight in standard behavioral weight loss interventions. A potential reason for smaller weight loss is that compared to NHW women, AA women have been shown to engage in less physical activity (PA) during these interventions.
The Sisters in Health study will test the efficacy of a 6-month randomized controlled trial in overweight and obese African American women. Women will be recruited to participate in this study comparing a standard behavioral weight loss intervention (BWI) to a physical activity enhanced BWI (BWI-PA) for 6 months. The primary objective of this study is to determine if AA women randomized to the BWI-PA will experience greater weight loss and PA compared to women receiving the BWI. Women in both groups will receive 18 face-to-face sessions on a tapered basis (weekly to biweekly). Face-to-face sessions will provide women with the knowledge, behavioral skills and strategies for weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Enhanced Weight Loss Intervention | Experimental | Behavioral: Physical Activity Enhanced Weight Loss InterventionParticipants will engage in 18 weight loss intervention group sessions over 6 months. Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months. Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations. This arm, uniquely, will receive a culturally based physical activity component. |
| Standard Weight Loss Intervention | Active comparator | Behavioral: Standard Weight Loss InterventionParticipants will engage in 18 weight loss intervention group sessions over 6 months. Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months. Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 21-65 years old
- Ability to read, write, and speak English
Key exclusion criteria (8 listed)
- Recently lost weight, 5-10% in last 6 months
- Currently participating in another weight loss or PA study, or taking weight loss medication, and unwilling to discontinue those activities
- Pregnant or planning to become pregnant
- Any physical limitations to engaging in or increasing physical activity/exercise- assessed by PAR-Q (including but not limited to heart attack/myocardial infarction, congestive heart failure)
- Type 2 diabetes being treated with insulin
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 |
|---|---|---|
| Standard Weight Loss Intervention18 session, group-based, 6-month, standard behavioral weight loss intervention | Behavioural | Standard Weight Loss Intervention |
| Physical Activity Enhanced Weight Loss Intervention18 session, group-based, 6-month, physical activity enhanced behavioral weight loss intervention | Behavioural | Physical Activity Enhanced Weight Loss Intervention |
Primary outcome
Change in Weight
Time frame: Baseline to 6 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 18 Apr 2017.
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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.
Deborah F. Tate, PhD study chair
University of North Carolina, Chapel Hill
Loneke T. Blackman Carr, MA, RD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A study testing Standard Weight Loss Intervention and Physical Activity Enhanced Weight Loss Intervention in people with Obesity, run by University of North Carolina, Chapel Hill.
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 13 inclusion and 8 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 18 Apr 2017. 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?
Change in Weight (time frame: Baseline to 6 months). 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 18 Apr 2017.