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

NCT02253641 | Completed

• 1 other identifier: 14-2107
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

African American, Women; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Weight

  collect weight in pounds

  Change from Baseline to 6 Months

Secondary Outcomes (4)

• Physical Activity

  Change from Baseline to 6 Months

• Psychosocial & Behavioral Measures

  Change from Baseline to 6 Months

• Walkability

  Change from Baseline to 6 Months

• Aerobic Fitness

  Change from Baseline to 6 Months

Study Arms (2)

Standard Weight Loss Intervention

ACTIVE COMPARATOR

Participants will take part in a 14 session weight loss/healthy lifestyle intervention. Sessions will be 2 hours in length and will occur weekly for month 1 then bi-weekly for months 2 - 6. The core lifestyle curriculum content for both groups will come from the previously IRB-approved Weight Wise intervention developed by Samuel-Hodge et al. (Samuel-Hodge, Carmen D., et al. "Randomized Trial of a Behavioral Weight Loss Intervention for Low?income Women: The Weight Wise Program." Obesity 17.10 (2009): 1891-1899). The only modifications to the content (other than some general formatting) will be the combining of sessions 3 and 4 and sessions 6 and 7. These changes will allow us to fit the original 16-session curriculum into the 14-session format of our intervention.

Behavioral: Standard Weight Loss Intervention

Stress-Focused Weight Loss Intervention

EXPERIMENTAL

Participants will take part in a 14 session weight loss/healthy lifestyle intervention. Sessions will be 2 hours in length and will occur weekly for month 1 then bi-weekly for months 2 - 6. The core lifestyle curriculum content for both groups will come from the previously IRB-approved Weight Wise intervention developed by Samuel-Hodge et al.. The participants in this arm will receive all of the content that the comparison group receives (just moderately condensed to allow time for additional components) plus a stress-reduction intervention woven into each of the sessions. The stress-reduction content aims to reduce stress by helping participants: (1) identifying and reducing exposure (to the degree possible) of current stressors, (2) change their perceptions of current stressors and (3) use healthier stress-coping techniques (e.g. yoga, meditation, etc.)

Behavioral: Stress-Focused Weight Loss Intervention

Interventions

Standard Weight Loss Intervention BEHAVIORAL

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

Standard Weight Loss Intervention

Stress-Focused Weight Loss Intervention BEHAVIORAL

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

Stress-Focused Weight Loss Intervention

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

UNC Center for Health Promotion and Disease Prevention

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (7)

• 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.

  PMID: 23953862 BACKGROUND

• 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.

  PMID: 20935337 BACKGROUND

• 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, Sjostrom 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.

  PMID: 20101009 BACKGROUND

• 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.

  PMID: 18421273 BACKGROUND

• 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.

  PMID: 22505570 BACKGROUND

• 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.

  PMID: 10895842 BACKGROUND

• 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.

  PMID: 22074195 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Research Assistant

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 1, 2014
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

US (1)