Clinical trial NCT05337150: Remotely Delivered Behavioral Weight Loss Using an Ad Libitum Plant-Based Diet Versus a Balanced Calorie Deficit Diet
Official title: Evaluating a Remotely Delivered Behavioral Weight Loss Intervention Using an Ad Libitum Plant-Based Diet Versus a Balanced Calorie Deficit Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: vegetarian
behavioral weight loss
weight loss
dietary self-monitoring
obesity
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Weight Change
timeFrame: Measured at each assessment baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
Secondary outcomes:
measure: Subjective Appetite as assessed by visual analogue scale (VAS)
timeFrame: Measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
Other outcomes:
measure: Dietary adherence as assessed by food frequency questionnaire (FFQ)
timeFrame: Measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
measure: Quality of Life Change as assessed by the 36-item Short-Form General Health Survey (SF-36)
timeFrame: Measured at baseline, mid-treatment (12-weeks) and post-treatment (6-months).
measure: Intentions to continue adhering to dietary prescription as assessed by a Future Intentions Questionnaire
timeFrame: Measured at post-treatment (12-weeks and 6-months).
measure: Depressive Symptoms as assessed by the Beck Depression Inventory-II (BDI-II)
timeFrame: Measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
measure: Program acceptability as assessed by a program acceptability questionnaire
timeFrame: Measured at post-treatment (6-months).
measure: Dietary acceptability as assessed by a diet acceptability questionnaire
timeFrame: Measured at post-treatment (6-months).
measure: Association between social support vs. social sabotage (as assessed by Ball & Crawford) at Week 12 (mid-treatment) and percent weight loss at 6-months (post-treatment).
timeFrame: Measured at mid-treatment (12-weeks) and post-treatment (6-months).
measure: Fatigue as assessed by the FACIT Fatigue
timeFrame: Measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Evan Forman, PhD
role: PRINCIPAL_INVESTIGATOR
References: