Sisters in Health: A Weight Loss Study for African American Women

NCT02631018 | Completed

• 1 other identifier: 15-0484
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Weight

  Baseline to 6 months

Study Arms (2)

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.

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.

Behavioral: Standard Weight Loss Intervention

Interventions

Standard Weight Loss Intervention BEHAVIORAL

18 session, group-based, 6-month, standard behavioral weight loss intervention

Standard Weight Loss Intervention

Physical Activity Enhanced Weight Loss Intervention BEHAVIORAL

18 session, group-based, 6-month, physical activity enhanced behavioral weight loss intervention

Physical Activity Enhanced Weight Loss Intervention

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Academy of Nutrition and Dietetics: collaborator

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Deborah F. Tate, PhD

  University of North Carolina, Chapel Hill

  STUDY CHAIR

• Loneke T. Blackman Carr, MA, RD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 15, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04