Community Based Obesity Prevention Among Black Women

NCT ID: NCT00938535

Last Updated: 2014-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Obesity prevention among Black women is a major public health priority; presently, nearly 54% of the adult Black female population is obese. To date, most intervention attention has been focused on weight reduction among the overweight and obese. However, both conditions are notoriously recalcitrant to treatment, particularly among Blacks. We posit that obesity prevention might represent a particularly effective intervention strategy for overweight Black women. Most studies have shown that Black women have a greater social acceptance of overweight, less body weight dissatisfaction, and higher ideal body weights, compared to Whites. Furthermore, numerous studies have shown that obesity is less lethal and causes fewer co-morbidities among Black vs. White women, suggesting that maintaining overweight may be an appropriate public health goal for Black women. We posit that an intervention approach that emphasizes maintaining overweight, while preventing the transition to obesity will resonate among the target population. Very few obesity prevention RCTs appear in the published literature and, to our knowledge, none have been conducted solely among Black women.

We propose to randomize overweight, Black women (n=184) to either usual care (UC) or an obesity prevention (OP) intervention condition. The OP condition is comprised of several intervention components that will be delivered over 12 months; each participant will receive a tailored action plan, tailored print materials, monthly coaching calls, and weekly self-monitoring via an interactive voice response system. Assessments will be taken at baseline, 6, 12, and 18 months post baseline.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Obesity Prevention

Group Type EXPERIMENTAL

Obesity Prevention

Intervention Type BEHAVIORAL

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

Usual Care

This arm includes usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Obesity Prevention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

25 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary Bennett, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23979005 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32985131 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29037247 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28213632 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24780934 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22537222 (View on PubMed)

Other Identifiers

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1R01DK078798

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2628

Identifier Type: -

Identifier Source: org_study_id

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