Clinical trial NCT02253641: The STRENGTH Study: Shapely Sisters Targeting Realistic Exercise and Nutrition Goals Through Healthy Habits
Official title: The STRENGTH Study: Shapely Sisters Targeting Realistic Exercise and Nutrition Goals Through Healthy Habits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: African American, Women
Weight Loss
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Academy of Nutrition and Dietetics
First posted: 2014-10-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: Change from Baseline to 6 Months
Secondary outcomes:
measure: Physical Activity
timeFrame: Change from Baseline to 6 Months
measure: Psychosocial & Behavioral Measures
timeFrame: Change from Baseline to 6 Months
measure: Walkability
timeFrame: Change from Baseline to 6 Months
measure: Aerobic Fitness
timeFrame: Change from Baseline to 6 Months
Other outcomes:
Locations:
city: Chapel-Hill
country: United States
facility: UNC Center for Health Promotion and Disease Prevention
state: North Carolina
Study officials:
References:
citation: Fitzgerald KR. Review of article: Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010 by Katherine M. Flegal, PhD; Margaret D. Carroll, MSPH; Brian K. Kit, MD; Cynthia L. Ogden, PhD (JAMA 2012;307:491-7). J Vasc Nurs. 2013 Sep;31(3):131-2. doi: 10.1016/j.jvn.2013.06.004. No abstract available.
citation: Goodpaster BH, Delany JP, Otto AD, Kuller L, Vockley J, South-Paul JE, Thomas SB, Brown J, McTigue K, Hames KC, Lang W, Jakicic JM. Effects of diet and physical activity interventions on weight loss and cardiometabolic risk factors in severely obese adults: a randomized trial. JAMA. 2010 Oct 27;304(16):1795-802. doi: 10.1001/jama.2010.1505. Epub 2010 Oct 9.
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citation: West DS, Elaine Prewitt T, Bursac Z, Felix HC. Weight loss of black, white, and Hispanic men and women in the Diabetes Prevention Program. Obesity (Silver Spring). 2008 Jun;16(6):1413-20. doi: 10.1038/oby.2008.224. Epub 2008 Apr 10.
citation: Cox TL, Krukowski R, Love SJ, Eddings K, DiCarlo M, Chang JY, Prewitt TE, West DS. Stress management-augmented behavioral weight loss intervention for African American women: a pilot, randomized controlled trial. Health Educ Behav. 2013 Feb;40(1):78-87. doi: 10.1177/1090198112439411. Epub 2012 Apr 13.
citation: Samuel-Hodge CD, Headen SW, Skelly AH, Ingram AF, Keyserling TC, Jackson EJ, Ammerman AS, Elasy TA. Influences on day-to-day self-management of type 2 diabetes among African-American women: spirituality, the multi-caregiver role, and other social context factors. Diabetes Care. 2000 Jul;23(7):928-33. doi: 10.2337/diacare.23.7.928.
citation: Fitzgibbon ML, Tussing-Humphreys LM, Porter JS, Martin IK, Odoms-Young A, Sharp LK. Weight loss and African-American women: a systematic review of the behavioural weight loss intervention literature. Obes Rev. 2012 Mar;13(3):193-213. doi: 10.1111/j.1467-789X.2011.00945.x. Epub 2011 Nov 10.