Obesity-Related Malignant NeoplasmNCT04557540
Weight Loss Interventions for Black Adults of Faith
A study testing Lifestyle Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Obesity-Related Malignant Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity-Related Malignant Neoplasm
- What is being tested?
- Lifestyle Therapy, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2021to 7 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Comparison of Intermittent Fasting With Continuous Caloric Reduction in 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Obesity-Related Malignant Neoplasm
- Being tested
- Lifestyle Therapy, Quality-of-Life Assessment, Questionnaire Administration, Short-Term Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle TherapyBehavioural
Receive The WORD lifestyle CER weight loss intervention
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Short-Term FastingOther
Also called Intermittent Fasting, Short-term Intermittent Fasting
Receive Fasting WORD intermittent fasting weight loss intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Fasting WORD) | Experimental | 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. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Short-Term Fasting |
| Arm II (The WORD) | Experimental | 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. Receives: Behavioral: Lifestyle Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: Up to 6 months
Changes in body composition
Measured: up to 6 months
Change in height
Measured: up to 6 months
Change in heart rate
Measured: Up to 6 months
Change in blood pressure
Measured: AT 6 months
Change in waist circumference
Measured: Up to t 6 months
Change in hip circumference
Measured: Up to 6 months
Secondary outcomes (5)
Dietary intake
Dietary intake will be assessed by the interview-administered Nutrition Data System for Research (NDSR).
Measured: Up to 6 months
Obesity-related biomarker analysis
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.
Measured: Up to 6 months
glucose metabolism
Change from baseline
Measured: UP to 6 months
changes in Adipokine levels
blood concentration measure
Measured: Up to 6 months
C-Peptide level
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start25 Sep 2021
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity-Related Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Yeary, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557540
- Sponsor's protocol ID
- I 684220
- Other IDs
- NCI-2020-06640, I 684220
- Status last verified
- Jan 2024
- First submitted
- 9 Sep 2020
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intermittent Fasting With Continuous Caloric Reduction in Black Adults of Faith
- ClinicalTrials.gov ID
- NCT04557540
- Acronym / sponsor ID
- I 684220
- Conditions
- Obesity-Related Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 25 Sep 2021 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Fasting WORD) | Experimental | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Short-Term FastingParticipants 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. |
| Arm II (The WORD) | Experimental | Behavioral: Lifestyle Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle TherapyReceive The WORD lifestyle CER weight loss intervention | Behavioural | Arm II (The WORD) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (Fasting WORD), Arm II (The WORD) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (Fasting WORD), Arm II (The WORD) |
| Short-Term FastingAlso: Intermittent Fasting, Short-term Intermittent FastingReceive Fasting WORD intermittent fasting weight loss intervention | Other | Arm I (Fasting WORD) |
Primary outcome
Change in body weight
Time frame: Up to 6 months
Changes in body composition
Time frame: up to 6 months
Change in height
Time frame: up to 6 months
Change in heart rate
Time frame: Up to 6 months
Change in blood pressure
Time frame: AT 6 months
Change in waist circumference
Time frame: Up to t 6 months
Change in hip circumference
Time frame: Up to 6 months
5 secondary outcomes
Dietary intake
Time frame: Up to 6 months
Obesity-related biomarker analysis
Time frame: Up to 6 months
glucose metabolism
Time frame: UP to 6 months
changes in Adipokine levels
Time frame: Up to 6 months
C-Peptide level
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Yeary principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Obesity-Related Malignant Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Up to 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.