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ObesityNCT02253641

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

A study testing Standard Weight Loss Intervention and Stress-Focused Weight Loss Intervention in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Standard Weight Loss Intervention and Stress-Focused Weight Loss Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Apr 2015to Sep 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UNC Center for Health Promotion and Disease Prevention

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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.

Read the 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).

Conditions
Obesity
Being tested
Standard Weight Loss Intervention, Stress-Focused Weight Loss Intervention
Keywords
African American, Women, Weight Loss
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Weight Loss InterventionBehavioural

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

  • Stress-Focused Weight Loss InterventionBehavioural

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

Study groups in NCT02253641
Study groupRoleWhat they receive
Standard Weight Loss InterventionActive comparatorParticipants 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.
Receives: Behavioral: Standard Weight Loss Intervention
Stress-Focused Weight Loss InterventionExperimentalParticipants 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.)
Receives: Behavioral: Stress-Focused Weight Loss Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    collect weight in pounds

    Measured: Change from Baseline to 6 Months

Secondary outcomes (4)

  1. Physical Activity

    participants will wear accelerometer for 1 week at each time point

    Measured: Change from Baseline to 6 Months

  2. 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.

    Measured: Change from Baseline to 6 Months

  3. Walkability

    Stand Up and Go Test

    Measured: Change from Baseline to 6 Months

  4. Aerobic Fitness

    6 Minute Walk Test

    Measured: Change from Baseline to 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2014 (estimated)
  2. Study startApr 2015
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02253641
Sponsor's protocol ID
14-2107
Status last verified
Sep 2015
First submitted
25 Sep 2014
Last updated
22 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23953862

  • 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.

    PubMed 20935337

  • 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.

    PubMed 20101009

  • 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.

    PubMed 18421273

  • 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.

    PubMed 22505570

  • 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.

    PubMed 10895842

  • 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.

    PubMed 22074195

Questions about this trial

What is this clinical trial studying?

A study testing Standard Weight Loss Intervention and Stress-Focused Weight Loss Intervention in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: Change from Baseline to 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02253641, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.

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Clinical Trial NCT02253641 | AzTrials