Study Results
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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COMPLETED
NA
194 participants
INTERVENTIONAL
2009-11-30
2014-06-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Obesity Prevention
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.
Usual Care
This arm includes usual care.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 given birth within the past 12 months
* No history of myocardial infarction or stroke in last 2 years
25 Years
44 Years
FEMALE
No
Sponsors
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Duke University
OTHER
Responsible Party
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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
Countries
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2628
Identifier Type: -
Identifier Source: org_study_id
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