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
44 participants
INTERVENTIONAL
2021-09-25
2022-12-07
Brief Summary
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Detailed Description
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I. Partner with the First Ladies of Western New York (FLOW) to engage 10 community stakeholders from Black churches in the Roswell Park Catchment area in a four-stage process involving information gathering, discussion groups, and mock intervention delivery to create Fasting WORD for Black adults of faith.
II. Implement and determine the initial comparative effectiveness of Fasting WORD with The WORD to reduce body weight, and biomarkers of obesity, inflammation, insulin, and insulin resistance.
SECONDARY OBJECTIVES:
I. Examine the interventions' effects on diet and physical activity. II. Examine participants' adherence and satisfaction with both interventions.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive the Fasting WORD intermittent fasting weight loss intervention consisting of 16 small-group lessons over 1.5 hours each once a week (QW) for 2 months and then once every 2 weeks (Q2W) for 4 months.
ARM II: Participants receive The WORD continuous energy restriction (CER) weight loss intervention consisting of 16 small-group lessons over 1.5 hours each QW for 2 months and then Q2W for 4 months.
After completion of study, participants are followed up for 30 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm I (Fasting WORD)
Participants receive the Fasting WORD intermittent fasting weight loss intervention consisting of 16 small-group lessons over 1.5 hours each QW for 2 months and then Q2W for 4 months.
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Short-Term Fasting
Receive Fasting WORD intermittent fasting weight loss intervention
Arm II (The WORD)
Participants receive The WORD CER weight loss intervention consisting of 16 small-group lessons over 1.5 hours each QW for 2 months and then Q2W for 4 months.
Lifestyle Therapy
Receive The WORD lifestyle CER weight loss intervention
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Lifestyle Therapy
Receive The WORD lifestyle CER weight loss intervention
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Short-Term Fasting
Receive Fasting WORD intermittent fasting weight loss intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) \> 25 kg/m\^2
* Associated with a participating church through membership or participation in a church activity
* Cleared by a Primary Care Provider (PCP-Doctor) to be a part of the study
* Not currently on weight loss medications
* Not pregnant or lactating
* Has not lost at least 10% of their body weight in the last 6 months
* Has not had bariatric surgery in the last 10 years
* Able to walk unassisted and continuously for 10 minutes
Exclusion Criteria
* Adults unable to complete study measures in English
* Individuals who are not yet adults (infants, children, teenagers)
* Individuals who are pregnant or lactating
* Adults who have had a myocardial infarction (heart attack) or stroke without medical clearance from their primary care physician to participate in the study
* Adults who currently have type 1 or type 2 diabetes without medical clearance from their primary care physician to participate in the study
18 Years
ALL
Yes
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Karen Yeary
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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NCI-2020-06640
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 684220
Identifier Type: OTHER
Identifier Source: secondary_id
I 684220
Identifier Type: -
Identifier Source: org_study_id
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