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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253641
• Other study ID #: 14-2107
• Status: Completed
• Phase: N/A
• First received: September 25, 2014
• Last updated: September 20, 2015
• Start date: April 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Standard Weight Loss Intervention
14-session/6-month standard behavioral weight loss intervention
• Stress-Focused Weight Loss Intervention
14-session/6-month tailored behavioral weight loss intervention

Locations

Country	Name	City	State
United States	UNC Center for Health Promotion and Disease Prevention	Chapel-Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Academy of Nutrition and Dietetics

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. Review. — View 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. — View Citation

Ryan DH, Johnson WD, Myers VH, Prather TL, McGlone MM, Rood J, Brantley PJ, Bray GA, Gupta AK, Broussard AP, Barootes BG, Elkins BL, Gaudin DE, Savory RL, Brock RD, Datz G, Pothakamuri SR, McKnight GT, Stenlof K, Sjöström LV. Nonsurgical weight loss for extreme obesity in primary care settings: results of the Louisiana Obese Subjects Study. Arch Intern Med. 2010 Jan 25;170(2):146-54. doi: 10.1001/archinternmed.2009.508. — View 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. — View 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. Erratum in: Obesity (Silver Spring). 2009 Nov;17(11):2119-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	collect weight in pounds	Change from Baseline to 6 Months	No
Secondary	Physical Activity	participants will wear accelerometer for 1 week at each time point	Change from Baseline to 6 Months	No
Secondary	Psychosocial & Behavioral Measures	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.	Change from Baseline to 6 Months	No
Secondary	Walkability	Stand Up and Go Test	Change from Baseline to 6 Months	No
Secondary	Aerobic Fitness	6 Minute Walk Test	Change from Baseline to 6 Months	Yes