Clinical trial NCT02631018: Sisters in Health: A Weight Loss Study for African American Women
Official title: Sisters in Health: A Weight Loss Study for African American Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Academy of Nutrition and Dietetics
First posted: 2015-12-15
Enrollment: 84
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
  * 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Deborah F. Tate, PhD
role: STUDY_CHAIR
affiliation: University of North Carolina, Chapel Hill
name: Loneke T. Blackman Carr, MA, RD
role: PRINCIPAL_INVESTIGATOR
References: