ObesityNCT05337150
Remotely Delivered Behavioral Weight Loss Using an Ad Libitum Plant-Based Diet Versus a Balanced Calorie Deficit Diet
A study testing Lifestyle Modification Intervention, Balanced Calorie Deficit Eating Plan and Ad Libitum Whole Food Plant-Based Eating Plan in people with Obesity and Overweight, run by Drexel University at 1 site in United States.
Trial summary
This pilot randomized controlled trial will compare a remotely delivered behavioral weight loss program with a balanced calorie deficit diet (the current gold-standard) to a behavioral weight loss program with an ad libitum whole food plant-based diet (WFPBD) amongst adults with overweight/obesity (N = 52). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Lifestyle Modification Intervention, Balanced Calorie Deficit Eating Plan and Ad Libitum Whole Food Plant-Based Eating Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2022to 24 Mar 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 27-50 kg/m2
- Ages 18-75 years
- Resides in the U.S.
- Consistent access to internet at home
- Proficient skill level in speaking, writing, and understanding English
- Reporting a desire to lose weight
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- Consistently available for 15-minute once-weekly video appointment between the hours of 8 AM and 7 PM EST
- Willing to follow a whole food plant-based diet or a traditional calorie-reduced diet for the study duration
- Individuals must provide consent for the research team to contact their personal physician if necessary, to provide clearance or to consult about rapid weight loss
Who cannot join
- Currently pregnant or breastfeeding or planned pregnancy within the study period
- Recent weight loss (≥ 5% weight loss in 3-months prior to the study)
- History of bariatric surgery
- Currently following a low-fat plant-based diet
- Medical condition (e.g., cancer, type I diabetes, renal failure), current substance use problem, or psychiatric condition (e.g., active substance abuse, eating disorder) that may pose a risk to the participant during intervention or cause a change in weight
- Recently began or changed the dose of a medication that can cause significant change in weight
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- Planning on quitting cigarette smoking over the program period
- Participation in a concurrent weight loss program during the study period
- Medical diagnosis currently influencing weight or appetite
- Medical condition that would limit ability to participate in this program (for example, mild stroke, diabetes if taking insulin, head trauma, cognitive disorder)
- Acute suicidality
- Currently meets criteria for regular loss-of-control eating (i.e., ≥ 9 binge episodes in past 3 months
- Currently reports engaging in a compensatory behavior
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating a Remotely Delivered Behavioral Weight Loss Intervention Using an Ad Libitum Plant-Based Diet Versus a Balanced Calorie Deficit Diet
This pilot randomized controlled trial will compare a remotely delivered behavioral weight loss program with a balanced calorie deficit diet (the current gold-standard) to a behavioral weight loss program with an ad libitum whole food plant-based diet (WFPBD) amongst adults with overweight/obesity (N = 52). The 6-month intervention will consist of 3 months of moderate-intensity intervention (weekly online modules and brief coaching calls), then a low-intensity period (3 calls over 3-months). Assessments will occur at baseline, 6-weeks, 12-weeks, and post-treatment (6-months). Acceptability, dietary adherence, weight, quality of life, depressive symptoms, and subjective appetite will be assessed.
- Conditions
- Obesity, Overweight
- Being tested
- Lifestyle Modification Intervention, Balanced Calorie Deficit Eating Plan, Ad Libitum Whole Food Plant-Based Eating Plan
- Keywords
- vegetarian, behavioral weight loss, weight loss, dietary self-monitoring, obesity
- 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.
Lifestyle Modification InterventionBehavioural
For the first 12-weeks of the study, participants will complete weekly web modules in which they will learn cognitive-behavioral strategies to support lifestyle modification. Participants will also receive weekly phone coaching calls for the first 12-weeks of the study, and monthly coaching calls thereafter for the remainder of the 24-week study period.
Balanced Calorie Deficit Eating PlanBehavioural
Participants will be prescribed a calorie target between 1200 and 1800 depending upon baseline weight and personal preference. Participants will be asked to monitor their dietary intake using MyFitnessPal and to submit food logs weekly. Calorie reduction content will be based primarily on the Diabetes Prevention Program protocol and adapted from existing behavioral treatment protocols. Individuals will receive general guidelines on eating a healthy diet, including reducing saturated fat, processed foods, refined sugars, and refined carbohydrates, and increasing intake of lean proteins, whole grains, and fruits and vegetables, but will be encouraged to flexibly decide which areas of their diet to modify to reduce calorie intake.
Ad Libitum Whole Food Plant-Based Eating PlanBehavioural
Participants will be prescribed a whole food plant-based (WFPB) low-fat vegan diet promoting intake of fruits, vegetables, starches, legumes, and whole grains. Participants will be encouraged to avoid processed foods, refined oils, and animal products (meat, fish, eggs, and dairy products), and to minimize consumption of high-fat plant-based foods. An adapted traffic-light diet chart will outline foods to eat daily, limit, and avoid. Participants will be advised to eat until satiation and not restrict energy intake. Participants will be asked to consume 50 μg vitamin B12 (methylcobalamin) daily. WFPB nutrition counseling content will be based upon existing successful programs. Each week, participants will complete a simplified dietary self-monitoring food frequency questionnaire aligned to correspond with the traffic light diet chart.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Modification with a Balanced Calorie Deficit Diet | Experimental | Lifestyle modification intervention with a balanced calorie deficit diet (i.e., participants will be prescribed a calorie goal and will track their dietary intake in order to meet this goal). Receives: Behavioral: Lifestyle Modification Intervention; Behavioral: Balanced Calorie Deficit Eating Plan |
| Lifestyle Modification with an Ad Libitum Whole Food Plant-Based Eating Plan | Experimental | Lifestyle modification intervention with an ad libitum whole food plant-based diet (i.e., participants will eat, ad libitum, fruits, vegetables, starches, legumes, and whole grains, and will avoid eating processed foods, refined oils, and animal products) Receives: Behavioral: Lifestyle Modification Intervention; Behavioral: Ad Libitum Whole Food Plant-Based Eating Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
Weight loss will be self-reported by participants using a standardized weighing procedure. Participants will weigh themselves in lightweight clothes without shoes with a digital scale accurate to 0.1 kg. Percent weight loss at 6-months will be calculated as the percentage loss in initial body weight at baseline by the time of the post-treatment assessment.
Measured: Measured at each assessment baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
Secondary outcomes (1)
Subjective Appetite as assessed by visual analogue scale (VAS)
Subjective appetite will be assessed using 6 visual analogue scale items (VAS) inquiring about past-week hunger, fullness, the degree to which hunger made it difficult to follow the prescribed diet, preoccupation with thoughts of food, and being bothered by hunger on a visual analogue scale of 0-100. Scores on the fullness item will be reversed, such that higher scores will indicate greater subjective appetite.
Measured: Measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start29 May 2022
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evan Forman, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337150
- Sponsor's protocol ID
- HEALTHQUEST
- Status last verified
- Jan 2023
- First submitted
- 25 Mar 2022
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Remotely Delivered Behavioral Weight Loss Intervention Using an Ad Libitum Plant-Based Diet Versus a Balanced Calorie Deficit Diet
- ClinicalTrials.gov ID
- NCT05337150
- Acronym / sponsor ID
- HEALTHQUEST
- Conditions
- Obesity, Overweight
- Keywords
- vegetarian, behavioral weight loss, weight loss, dietary self-monitoring, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 29 May 2022 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 20 Apr 2022 (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 pilot randomized controlled trial will compare a remotely delivered behavioral weight loss program with a balanced calorie deficit diet (the current gold-standard) to a behavioral weight loss program with an ad libitum whole food plant-based diet (WFPBD) amongst adults with overweight/obesity (N = 52). The 6-month intervention will consist of 3 months of moderate-intensity intervention (weekly online modules and brief coaching calls), then a low-intensity period (3 calls over 3-months). Assessments will occur at baseline, 6-weeks, 12-weeks, and post-treatment (6-months). Acceptability, dietary adherence, weight, quality of life, depressive symptoms, and subjective appetite will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification with a Balanced Calorie Deficit Diet | Experimental | Behavioral: Lifestyle Modification Intervention, Behavioral: Balanced Calorie Deficit Eating PlanLifestyle modification intervention with a balanced calorie deficit diet (i.e., participants will be prescribed a calorie goal and will track their dietary intake in order to meet this goal). |
| Lifestyle Modification with an Ad Libitum Whole Food Plant-Based Eating Plan | Experimental | Behavioral: Lifestyle Modification Intervention, Behavioral: Ad Libitum Whole Food Plant-Based Eating PlanLifestyle modification intervention with an ad libitum whole food plant-based diet (i.e., participants will eat, ad libitum, fruits, vegetables, starches, legumes, and whole grains, and will avoid eating processed foods, refined oils, and animal products) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- BMI 27-50 kg/m2
- Ages 18-75 years
- Resides in the U.S.
- Consistent access to internet at home
- Proficient skill level in speaking, writing, and understanding English
Key exclusion criteria (13 listed)
- Currently pregnant or breastfeeding or planned pregnancy within the study period
- Recent weight loss (≥ 5% weight loss in 3-months prior to the study)
- History of bariatric surgery
- Currently following a low-fat plant-based diet
- Medical condition (e.g., cancer, type I diabetes, renal failure), current substance use problem, or psychiatric condition (e.g., active substance abuse, eating disorder) that may pose a risk to the participant during intervention or cause a change in weight
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 Modification InterventionFor the first 12-weeks of the study, participants will complete weekly web modules in which they will learn cognitive-behavioral strategies to support lifestyle modification. Participants will also receive weekly phone coaching calls for the first 12-weeks of the study, and monthly coaching calls thereafter for the remainder of the 24-week study period. | Behavioural | Lifestyle Modification with a Balanced Calorie Deficit Diet, Lifestyle Modification with an Ad Libitum Whole Food Plant-Based Eating Plan |
| Balanced Calorie Deficit Eating PlanParticipants will be prescribed a calorie target between 1200 and 1800 depending upon baseline weight and personal preference. Participants will be asked to monitor their dietary intake using MyFitnessPal and to submit food logs weekly. Calorie reduction content will be based primarily on the Diabetes Prevention Program protocol and adapted from existing behavioral treatment protocols. Individuals will receive general guidelines on eating a healthy diet, including reducing saturated fat, processed foods, refined sugars, and refined carbohydrates, and increasing intake of lean proteins, whole grains, and fruits and vegetables, but will be encouraged to flexibly decide which areas of their diet to modify to reduce calorie intake. | Behavioural | Lifestyle Modification with a Balanced Calorie Deficit Diet |
| Ad Libitum Whole Food Plant-Based Eating PlanParticipants will be prescribed a whole food plant-based (WFPB) low-fat vegan diet promoting intake of fruits, vegetables, starches, legumes, and whole grains. Participants will be encouraged to avoid processed foods, refined oils, and animal products (meat, fish, eggs, and dairy products), and to minimize consumption of high-fat plant-based foods. An adapted traffic-light diet chart will outline foods to eat daily, limit, and avoid. Participants will be advised to eat until satiation and not restrict energy intake. Participants will be asked to consume 50 μg vitamin B12 (methylcobalamin) daily. WFPB nutrition counseling content will be based upon existing successful programs. Each week, participants will complete a simplified dietary self-monitoring food frequency questionnaire aligned to correspond with the traffic light diet chart. | Behavioural | Lifestyle Modification with an Ad Libitum Whole Food Plant-Based Eating Plan |
Primary outcome
Weight Change
Time frame: Measured at each assessment baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
Weight loss will be self-reported by participants using a standardized weighing procedure. Participants will weigh themselves in lightweight clothes without shoes with a digital scale accurate to 0.1 kg. Percent weight loss at 6-months will be calculated as the percentage loss in initial body weight at baseline by the time of the post-treatment assessment.
1 secondary outcome
Subjective Appetite as assessed by visual analogue scale (VAS)
Time frame: Measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (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 14 Sep 2023.
- Individual participant dataSharing planned: No
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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 Forman, PhD 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 Lifestyle Modification Intervention, Balanced Calorie Deficit Eating Plan and Ad Libitum Whole Food Plant-Based Eating Plan 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 9 inclusion and 13 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 14 Sep 2023. 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?
Weight Change (time frame: Measured at each assessment baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).). 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 14 Sep 2023.