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Completed

NCT Number: NCT04557540

Weight Loss Interventions for Black Adults of Faith

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Therapy

Behavioral

Receive The WORD lifestyle CER weight loss intervention

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Short-Term Fasting

Other

Receive Fasting WORD intermittent fasting weight loss intervention

Other names: Intermittent Fasting, Short-term Intermittent Fasting

Primary outcomes

  1. Change in body weight

    Time frame: Up to 6 months

  2. Changes in body composition

    Time frame: up to 6 months

  3. Change in height

    Time frame: up to 6 months

  4. Change in heart rate

    Time frame: Up to 6 months

  5. Change in blood pressure

    Time frame: AT 6 months

  6. Change in waist circumference

    Time frame: Up to t 6 months

  7. Change in hip circumference

    Time frame: Up to 6 months

Secondary outcomes

  1. Dietary intake

    Time frame: Up to 6 months

    Dietary intake will be assessed by the interview-administered Nutrition Data System for Research (NDSR).

  2. Obesity-related biomarker analysis

    Time frame: 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.

  3. glucose metabolism

    Time frame: UP to 6 months

    Change from baseline

  4. changes in Adipokine levels

    Time frame: Up to 6 months

    blood concentration measure

  5. C-Peptide level

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

Comparison of Intermittent Fasting With Continuous Caloric Reduction in Black Adults of Faith

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2020
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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