Weight Loss Interventions for Black Adults of Faith

Roswell Park Comprehensive Cancer Center

Status: Completed

Conditions: Obesity-Related Malignant Neoplasm

Treatments: Other: Questionnaire Administration; Behavioral: Lifestyle Therapy; Other: Short-Term Fasting; Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04557540

I 684220 (Other Identifier)

NCI-2020-06640 (Registry Identifier)

Details and patient eligibility

About

This trial compares the effect of intermittent fasting versus continuous caloric reduction for the reduction of body weight in Black adults of faith. Intermittent fasting and continuous caloric reduction interventions may help Black adults of faith lose weight, improve their health, and help reduce cancer risk.

Full description

PRIMARY OBJECTIVES:

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• African American/Black
• 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 consent
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Arm I (Fasting WORD)

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Short-Term Fasting

Other: Questionnaire Administration

Arm II (The WORD)

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Behavioral: Lifestyle Therapy

Other: Questionnaire Administration