Obesity-Related Malignant Neoplasm
Conditions
Brief summary
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.
Detailed 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.
Interventions
BEHAVIORALLifestyle Therapy
Receive The WORD lifestyle CER weight loss intervention
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
OTHERShort-Term Fasting
Receive Fasting WORD intermittent fasting weight loss intervention
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hip circumference | Up to 6 months |
| Changes in body composition | up to 6 months |
| Change in height | up to 6 months |
| Change in heart rate | Up to 6 months |
| Change in blood pressure | AT 6 months |
| Change in waist circumference | Up to t 6 months |
| Change in body weight | Up to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Obesity-related biomarker analysis | Up to 6 months | Will measure biomarkers related to , including C-peptide, as a marker of insulin secretion Will assay for 6 adipokines including leptin, adiponectin, adipsin, lipocalin-2/NGAL, resistin, and PAI-1 (total) as markers of adiposity and adiposity-related metabolic dysfunction, including insulin resistance, and CRP as a well-characterized and validated marker for systemic inflammation. |
| glucose metabolism | UP to 6 months | Change from baseline |
| changes in Adipokine levels | Up to 6 months | blood concentration measure |
| C-Peptide level | Up to 6 months | — |
| Dietary intake | Up to 6 months | Dietary intake will be assessed by the interview-administered Nutrition Data System for Research (NDSR). |
Countries
United States
Outcome results
None listed