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Completed

NCT Number: NCT02253641

The STRENGTH Study: Shapely Sisters Targeting Realistic Exercise and Nutrition Goals Through Healthy Habits

This study evaluates the efficacy of a stress-focused tailored weight loss intervention compared to a standard weight loss intervention on weight loss in severely obese (BMI > 40.0) African American women.

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Key information

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC Center for Health Promotion and Disease Prevention

Chapel Hill, North Carolina, 27599, United States

About this study

Stress has been identified as a major barrier to engaging in healthy lifestyle behaviors (e.g. diet and exercise) among African American women. African American women consistently lose less weight than their Caucasian counterparts in weight loss interventions. One reason for this disparity may be due to the failure of most weight loss interventions to address stress management adequately or in a culturally competent way.

The purpose of this study is to evaluate the efficacy of a stress-focused tailored weight loss intervention compared to a standard weight loss intervention on weight loss in severely obese (BMI > 40.0) African American women. The stress-focused weight loss intervention will incorporate stress management content throughout the entire intervention and will include content that is culturally tailored. The standard weight loss intervention will cover stress management techniques during one of the 14 sessions and the material will be more generic in nature (e.g. not culturally tailored).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • African American (self-identified)
  • Female
  • BMI > 40 kg/m2
  • Access to internet connection and phone for personal use

Exclusion criteria

  • Unable to walk without the use of an assistance device
  • Failure to pass the Physical Activity Readiness Questionnaire (PAR-Q) or unable to attain medical clearance from their doctor
  • Substance abuse within past two years
  • Schizophrenia
  • Currently pregnant, pregnant within the past 6 months or plans to become pregnant in the next 6 months
  • History of malignancy other than non-melanoma skin cancer, that has not been in remission or cured surgically for > 5 years
  • Participation in a weight loss program in the past 12 months
  • > 5% loss of body weight within the past 6 months
  • Bariatric surgery recipient
  • Heart attack in the past 6 months
  • Stroke within the past 6 months

NOTE: Participants who "fail" the PAR-Q will be required to obtain medical clearance from their medical provider

Treatment and study plan

Standard weight loss intervention

Behavioral

14-session/6-month standard behavioral weight loss intervention

Stress-Focused Weight Loss Intervention

Behavioral

14-session/6-month tailored behavioral weight loss intervention

Primary outcomes

  1. Weight

    Time frame: Change from Baseline to 6 Months

    collect weight in pounds

Secondary outcomes

  1. Physical Activity

    Time frame: Change from Baseline to 6 Months

    participants will wear accelerometer for 1 week at each time point

  2. Psychosocial & Behavioral Measures

    Time frame: Change from Baseline to 6 Months

    Participants will complete a survey that will assess varying psychosocial and behavioral measures including: (1) diet and exercise habits, (2) stress levels, (3) moods and (4) attitudes and beliefs regarding female stereotypes.

  3. Walkability

    Time frame: Change from Baseline to 6 Months

    Stand Up and Go Test

  4. Aerobic Fitness

    Time frame: Change from Baseline to 6 Months

    6 Minute Walk Test

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Academy of Nutrition and Dietetics

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 1, 2014
Registry last updated
Sep 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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