NCT00938535

Brief Summary

This study will evaluate the efficacy of a behavioral intervention, designed to prevent weight gain among overweight and low obese (25-34.9 kg/m2) Black women (aged 25-44), compared to usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

2.9 years

First QC Date

July 10, 2009

Last Update Submit

July 28, 2014

Conditions

Obesity

Keywords

ObesityWomen's healthMinority healthObesity prevention

Outcome Measures

Primary Outcomes (1)

  • Change in BMI. We have set a target of BMI maintenance among those randomized to the intervention condition.

    6, 12 and 18 months post baseline

Secondary Outcomes (4)

  • Change in obesity risk behaviors

    6, 12 and 18 months post baseline

  • Measures of body composition

    6, 12 and 18 months post baseline

  • Psychosocial mediators

    6, 12 and 18 months post baseline

  • Obesity related biomarkers

    6, 12 and 18 months post baseline

Study Arms (2)

Obesity Prevention

EXPERIMENTAL
Behavioral: Obesity Prevention

Usual Care

NO INTERVENTION

This arm includes usual care.

Interventions

Obesity PreventionBEHAVIORAL

This arm includes an action plan, tailored print materials, telephone support calls, interactive self-monitoring, and a 12-month YMCA membership for the participant.

Obesity Prevention

Eligibility Criteria

Age25 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • African-American
  • Female
  • Ages 25-44
  • BMI between 25-34.9 kg/m2
  • Patients with at least 1 visit in the previous 24 months to a participating Community Health Center

You may not qualify if:

  • Not currently pregnant
  • Not given birth within the past 12 months
  • No history of myocardial infarction or stroke in last 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (6)

  • Bennett GG, Foley P, Levine E, Whiteley J, Askew S, Steinberg DM, Batch B, Greaney ML, Miranda H, Wroth TH, Holder MG, Emmons KM, Puleo E. Behavioral treatment for weight gain prevention among black women in primary care practice: a randomized clinical trial. JAMA Intern Med. 2013 Oct 28;173(19):1770-7. doi: 10.1001/jamainternmed.2013.9263.

    PMID: 23979005RESULT

  • Gallis JA, Kusibab K, Egger JR, Olsen MK, Askew S, Steinberg DM, Bennett G. Can Electronic Health Records Validly Estimate the Effects of Health System Interventions Aimed at Controlling Body Weight? Obesity (Silver Spring). 2020 Nov;28(11):2107-2115. doi: 10.1002/oby.22958. Epub 2020 Sep 27.

    PMID: 32985131DERIVED

  • Greaney ML, Askew S, Wallington SF, Foley PB, Quintiliani LM, Bennett GG. The effect of a weight gain prevention intervention on moderate-vigorous physical activity among black women: the Shape Program. Int J Behav Nutr Phys Act. 2017 Oct 16;14(1):139. doi: 10.1186/s12966-017-0596-6.

    PMID: 29037247DERIVED

  • Steinberg DM, Christy J, Batch BC, Askew S, Moore RH, Parker P, Bennett GG. Preventing Weight Gain Improves Sleep Quality Among Black Women: Results from a RCT. Ann Behav Med. 2017 Aug;51(4):555-566. doi: 10.1007/s12160-017-9879-z.

    PMID: 28213632DERIVED

  • Steinberg DM, Levine EL, Lane I, Askew S, Foley PB, Puleo E, Bennett GG. Adherence to self-monitoring via interactive voice response technology in an eHealth intervention targeting weight gain prevention among Black women: randomized controlled trial. J Med Internet Res. 2014 Apr 29;16(4):e114. doi: 10.2196/jmir.2996.

    PMID: 24780934DERIVED

  • Foley P, Levine E, Askew S, Puleo E, Whiteley J, Batch B, Heil D, Dix D, Lett V, Lanpher M, Miller J, Emmons K, Bennett G. Weight gain prevention among black women in the rural community health center setting: the Shape Program. BMC Public Health. 2012 Jun 15;12:305. doi: 10.1186/1471-2458-12-305.

    PMID: 22537222DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gary Bennett, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 14, 2009

Study Start

November 1, 2009

Primary Completion

October 1, 2012

Study Completion

June 1, 2014

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

US(1)