ObesityNCT04892030
Evaluating a Remotely Delivered Plant-Based Behavioral Weight Loss Treatment
A study testing Whole Food Plant-Based Behavioral Weight Loss Treatment in people with Obesity and Overweight, run by Drexel University at 1 site in United States.
Trial summary
Many individuals do not achieve clinically significant weight loss following traditional lifestyle modification interventions, potentially because weight loss is dependent upon calorie tracking compliance (to achieve calorie prescriptions), which decreases over time for most. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Whole Food Plant-Based Behavioral Weight Loss Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2020to 18 May 2021
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-75
- Current BMI ≥ 25 kg/m2
- Reporting a desire to lose weight
- Have at-home internet access
- Proficiency in speaking, reading, and writing English
- Willing to consume a whole foods plant-based diet for the study duration
Who cannot join
- Use of medications for weight loss
- Recent weight loss (≥5% weight loss in prior 3-months)
- Current or planned pregnancy within the study period
- History of bariatric surgery
- Currently following a low-fat plant-based diet
- Diagnosis of a serious medical condition influencing weight, appetite, or eating behavior
Show all 11Show fewer
- Diagnosis of a serious psychiatric condition that may influence weight, appetite, or eating behavior
- Current substance use disorder
- Participation in a concurrent weight loss program
- Planning on quitting smoking over the intervention period (if current smoker)
- Eating pathology (lifetime history of an eating disorder, ≥ 9 binge eating episodes in the past 3 months, or > 5 compensatory episodes in the past 3 months)
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Eating and Lifestyle Science Center, Drexel University
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Study of a Novel Ad Libitum Plant-Based Behavioral Weight Loss Treatment
Many individuals do not achieve clinically significant weight loss following traditional lifestyle modification interventions, potentially because weight loss is dependent upon calorie tracking compliance (to achieve calorie prescriptions), which decreases over time for most. By contrast, non-energy-restricted whole food plant-based diets (WFPBD) have been demonstrated to promote clinically significant weight loss even without calorie prescriptions. The present pilot trial represents the first, to the knowledge of our study team, to empirically test a remotely delivered WFPBD behavioral weight loss intervention for adults with overweight or obesity. Over 12-weeks, participants (N = 21) will follow a non-energy-restricted WFPBD and received nutritional counseling and behavioral weight loss intervention. Participation will occur in two phases (Phase 1: n = 7; Phase 2: n = 14), between which iterative changes to the intervention will be made. Assessments will occur at baseline, mid-treatment, post-treatment, and 3-month follow-up. Data will be analyzed using an intent-to-treat approach. The primary aims of the study will be to assess retention feasibility and acceptability. The secondary aims will be to evaluate the preliminary effectiveness of the intervention on: (1) percent weight loss; (2) dietary intake (i.e., increased intake of low-fat plant-based whole foods and decreased in intake of processed foods and animal products); and (3) waist circumference. The exploratory aims will be to evaluate the preliminary effectiveness of the intervention on physical- and mental health-related quality of life, and to examine potential moderators of treatment success (plant-based diet history, internal disinhibition, social support vs. social sabotage, self-compassion, and psychological flexibility).
- Conditions
- Obesity, Overweight
- Being tested
- Whole Food Plant-Based Behavioral Weight Loss Treatment
- Keywords
- Weight loss, Behavioral weight loss, Overweight and obesity, Plant-based, Lifestyle modification
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Food Plant-Based Behavioral Weight Loss TreatmentBehavioural
Over the course of 12-weeks, participants will be prescribed a non-energy-restricted whole food plant-based diet and will learn behavioral weight loss strategies through an e-learning platform. Each week, participants will also complete a 15-minute coaching call to provide positive reinforcement and problem-solving support.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All participants will be prescribed a non-energy-restricted whole food plant-based diet and will learn behavioral weight loss strategies remotely, through an e-learning platform. Receives: Behavioral: Whole Food Plant-Based Behavioral Weight Loss Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention feasibility as assessed by the number of participants successfully retained in the intervention
The number of participants who are retained in the study, as defined by completing the post-treatment assessment and at least 10 out of 12 of the weekly intervention modules. Successful retention will be defined as at least 80% of participants being retained in the study.
Measured: Week 12 (post-intervention)
Acceptability as assessed by self-reported acceptability of the intervention
Acceptability will be assessed with three items, in which participants will report the degree to which they were satisfied with the intervention, found the intervention to be helpful, and the likelihood that they would recommend it to family/friends on a Likert scale ranging from 1 (Not at all) to 5 (Very much).
Measured: Week 12 (post-intervention)
Secondary outcomes (3)
Preliminary effectiveness of the intervention on weight loss, as assessed by self-reported weight from baseline to post-intervention
Weight loss will be self-reported by participants weekly, and at baseline, mid-treatment, post-treatment, and 3-month follow-up. To evaluate the preliminary effectiveness of the intervention on weight loss, percent weight change from baseline to post-intervention will be evaluated. Preliminary weight loss effectiveness will be defined as at least 50% of participants losing at least 5% of their initial body weight by post-treatment.
Measured: Measured once weekly from Week 0 (baseline) to Week 12 (post-intervention), and at 3-month follow-up
Preliminary effectiveness of the intervention on dietary intake, as assessed by self-reported dietary intake from baseline to post-intervention
Dietary intake will be assessed using a food frequency questionnaire tailored to examine adherence to the prescribed intervention (whole food plant-based) diet. A dietary adherence index ranging from 0 (no adherence) to 100 (complete adherence) will be created, and preliminary dietary change effectiveness will be defined as at least 80% of participants improved their dietary adherence score by at least 20% by post-treatment.
Measured: Week 0 (baseline), Week 6 (mid-treatment), Week 12 (post-intervention), and 3-month follow-up
Preliminary effectiveness of the intervention on waist circumference, as assessed by self-reported waist circumference from baseline to post-intervention
Waist circumference will be self-reported by participants weekly, and at baseline, mid-treatment, post-treatment, and 3-month follow-up. To evaluate the preliminary effectiveness of the intervention on waist circumference, waist circumference change from baseline to post-intervention will be examined. Preliminary weight loss effectiveness will be defined as at least 50% of participants losing at least 5% of their initial waist circumference by post-treatment.
Measured: Week 0 (baseline), Week 6 (mid-treatment), Week 12 (post-intervention), and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start25 Nov 2020
- Primary completion18 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evan Forman, Drexel University
- Investigators
- Evan M Forman, Ph.D., Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892030
- Sponsor's protocol ID
- EATVEG838
- Status last verified
- Jun 2021
- First submitted
- 6 May 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared in a public repository stripped of any identifying participant information.
Publications
Chwyl C, Wright N, M Turner-McGrievy G, L Butryn M, M Forman E. Remotely Delivered Behavioral Weight Loss Intervention Using an Ad Libitum Plant-Based Diet: Pilot Acceptability, Feasibility, and Preliminary Results. JMIR Form Res. 2022 Jun 23;6(6):e37414. doi: 10.2196/37414.
PubMed 35737443
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Novel Ad Libitum Plant-Based Behavioral Weight Loss Treatment
- ClinicalTrials.gov ID
- NCT04892030
- Acronym / sponsor ID
- EATVEG838
- Conditions
- Obesity, Overweight
- Keywords
- Weight loss, Behavioral weight loss, Overweight and obesity, Plant-based, Lifestyle modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 19 May 2021 (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.
Many individuals do not achieve clinically significant weight loss following traditional lifestyle modification interventions, potentially because weight loss is dependent upon calorie tracking compliance (to achieve calorie prescriptions), which decreases over time for most. By contrast, non-energy-restricted whole food plant-based diets (WFPBD) have been demonstrated to promote clinically significant weight loss even without calorie prescriptions. The present pilot trial represents the first, to the knowledge of our study team, to empirically test a remotely delivered WFPBD behavioral weight loss intervention for adults with overweight or obesity. Over 12-weeks, participants (N = 21) will follow a non-energy-restricted WFPBD and received nutritional counseling and behavioral weight loss intervention. Participation will occur in two phases (Phase 1: n = 7; Phase 2: n = 14), between which iterative changes to the intervention will be made. Assessments will occur at baseline, mid-treatment, post-treatment, and 3-month follow-up. Data will be analyzed using an intent-to-treat approach. The primary aims of the study will be to assess retention feasibility and acceptability. The secondary aims will be to evaluate the preliminary effectiveness of the intervention on: (1) percent weight loss; (2) dietary intake (i.e., increased intake of low-fat plant-based whole foods and decreased in intake of processed foods and animal products); and (3) waist circumference. The exploratory aims will be to evaluate the preliminary effectiveness of the intervention on physical- and mental health-related quality of life, and to examine potential moderators of treatment success (plant-based diet history, internal disinhibition, social support vs. social sabotage, self-compassion, and psychological flexibility).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Whole Food Plant-Based Behavioral Weight Loss TreatmentAll participants will be prescribed a non-energy-restricted whole food plant-based diet and will learn behavioral weight loss strategies remotely, through an e-learning platform. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-75
- Current BMI ≥ 25 kg/m2
- Reporting a desire to lose weight
- Have at-home internet access
- Proficiency in speaking, reading, and writing English
Key exclusion criteria (11 listed)
- Use of medications for weight loss
- Recent weight loss (≥5% weight loss in prior 3-months)
- Current or planned pregnancy within the study period
- History of bariatric surgery
- Currently following a low-fat plant-based diet
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 |
|---|---|---|
| Whole Food Plant-Based Behavioral Weight Loss TreatmentOver the course of 12-weeks, participants will be prescribed a non-energy-restricted whole food plant-based diet and will learn behavioral weight loss strategies through an e-learning platform. Each week, participants will also complete a 15-minute coaching call to provide positive reinforcement and problem-solving support. | Behavioural | Intervention |
Primary outcome
Retention feasibility as assessed by the number of participants successfully retained in the intervention
Time frame: Week 12 (post-intervention)
The number of participants who are retained in the study, as defined by completing the post-treatment assessment and at least 10 out of 12 of the weekly intervention modules. Successful retention will be defined as at least 80% of participants being retained in the study.
Acceptability as assessed by self-reported acceptability of the intervention
Time frame: Week 12 (post-intervention)
Acceptability will be assessed with three items, in which participants will report the degree to which they were satisfied with the intervention, found the intervention to be helpful, and the likelihood that they would recommend it to family/friends on a Likert scale ranging from 1 (Not at all) to 5 (Very much).
3 secondary outcomes
Preliminary effectiveness of the intervention on weight loss, as assessed by self-reported weight from baseline to post-intervention
Time frame: Measured once weekly from Week 0 (baseline) to Week 12 (post-intervention), and at 3-month follow-up
Preliminary effectiveness of the intervention on dietary intake, as assessed by self-reported dietary intake from baseline to post-intervention
Time frame: Week 0 (baseline), Week 6 (mid-treatment), Week 12 (post-intervention), and 3-month follow-up
Preliminary effectiveness of the intervention on waist circumference, as assessed by self-reported waist circumference from baseline to post-intervention
Time frame: Week 0 (baseline), Week 6 (mid-treatment), Week 12 (post-intervention), and 3-month follow-up
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 1 Jul 2021.
- Derived from this study: PubMed 35737443Chwyl C, Wright N, M Turner-McGrievy G, L Butryn M, M Forman E. Remotely Delivered Behavioral Weight Loss Intervention Using an Ad Libitum Plant-Based Diet: Pilot Acceptability, Feasibility, and Preliminary Results. JMIR Form Res. 2022 Jun 23;6(6):e37414. doi: 10.2196/37414.
- Individual participant dataSharing planned: Yes. Data will be shared in a public repository stripped of any identifying participant information.
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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.
Evan M Forman, Ph.D. principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Food Plant-Based Behavioral Weight Loss Treatment in people with Obesity and Overweight, run by Drexel University 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 6 inclusion and 11 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 1 Jul 2021. 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?
Retention feasibility as assessed by the number of participants successfully retained in the intervention (time frame: Week 12 (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04892030, which also lists 1 linked publication.
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 1 Jul 2021.