Drexel University
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT05337150
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: Measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
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.
Time frame: Measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
Dietary adherence in the whole food plant-based diet (WFPBD) condition will be assessed with an adapted 7-item food frequency questionnaire (FFQ). Each day for 7 days, participants will indicate whether they ate each of the "green zone" food categories (veggies/fruits, leafy greens, whole gains/starches, beans/lentils), whether they ate less than 3 servings of "yellow zone" foods, the "red-zone" foods consumed (and servings of). To evaluate whether intake of green/yellow/red-zone foods changes more in the WFPBD condition than in the balanced calorie deficit diet (BCDD) condition, those in the BCDD condition will complete the FFQ at each assessment point. To evaluate dietary adherence in the BCDD condition, calorie-tracking adherence will be examined. Dietary adherence on a given day will be defined as the overall number of days participants tracked at least two eating occasions.
Time frame: Measured at baseline, mid-treatment (12-weeks) and post-treatment (6-months).
Quality of life will be assessed using the 36-item Short-Form General Health Survey (SF-36; Ware, Kosinski, & Keller, 1994; Ware & Sherbourne, 1992), which assesses eight domains: physical functioning, limits due to physical health, pain, general health, energy/fatigue, social functioning, emotional wellbeing, and mental health. Scores will be converted to a 0 to 100 scale, with higher scores indicating better functioning. This scale produces both physical health (PH) and mental health (MH) component summaries.
Time frame: Measured at post-treatment (12-weeks and 6-months).
Intentions to continue adhering to dietary prescription will be assessed with a 3-item self-report measure ("Future Intentions Questionnaire"). On a Likert scale ranging from 1 (Not at all) to 5 (Completely), participants will respond to face-valid questions asking about plans to continue adhering to the prescribed program diet (sample item: "I plan to follow the diet from this program moving forward") and the feasibility of the program diet (sample item: "The diet in this program is straightforward to follow moving forward"). Accompanying the measure, participants will receive a brief reminder of their dietary prescription (i.e., the traffic light diet chart in the whole food plant-based diet condition, or the calorie goal and daily calorie tracking requirement in the balanced calorie deficit diet condition). Items will be averaged to create a measure of intentions to adhere to the prescribed diet; higher scores indicate greater adherence.
Time frame: Measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
To assess depressive symptoms, the Beck Depression Inventory-II (BDI-II; Dozois et al., 1998) will be administered-a 21-item measure of somatic (e.g., appetite), affective (e.g., sadness) and cognitive (e.g., self-criticalness) dimensions of depressive symptomology. Participants will indicate how they have been feeling during the past week and make responses on a Likert scale ranging from 0 (e.g., I don't cry any more than I used to) to 3 (e.g., I feel like crying but I can't), with higher scores indicating greater levels of depressive symptoms.
Time frame: Measured at post-treatment (6-months).
Overall program acceptability will be assessed post-treatment with a questionnaire adapted from prior work (Bradley et al., 2017) that will ask participants to report how satisfied they were with the program, the degree to which they found the program helpful, and the likelihood they would recommend it to family or friends using a Likert scale ranging from 1 (Not at all) to 5 (Very much). Scores will be averaged across conditions to create mean program acceptability scores. Higher scores will indicate greater program acceptability.
Time frame: Measured at post-treatment (6-months).
Participants will indicate the degree to which they found their diet to be acceptable by indicating, on a Likert scale, how difficult they found the diet to follow (1-Very Easy - 5-Very difficult) with regards to: following the diet as a whole, cooking, dietary tracking, staying full, and managing cravings. Participants will also indicate how time-consuming they found their diet (1-Not at all time-consuming - 5-Very time-consuming), and how confident they felt in their ability to follow their diet (1-Not at all - 5-Very much so). Scores will be averaged across items to create mean dietary acceptability scores.
Time frame: Measured at mid-treatment (12-weeks) and post-treatment (6-months).
To assess social support vs. social sabotage, participants will complete the Social Support and Sabotage Scale from Ball & Crawford (2006). On this measure, participants separately rate the degree to which friends and family act in ways that support or hinder their healthy eating efforts with a Likert scale ranging from 1 (Almost never) to 5 (Almost always). Scores will be averaged for each subscale to compute: 1) support for health behaviors from friends, 2) support for health behaviors from family, 3) sabotage for health behaviors from friends, and 4) sabotage for health behaviors from family.
Time frame: Measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
Self-reported fatigue will be measured using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT Fatigue), a 13-item self-report questionnaire that assesses level of fatigue during an individual's usual daily activities over the past week on a Likert scale ranging from 4 (not at all fatigued) to 0 (very much fatigued) (Webster et al., 2003). Scores will be reversed such that higher scores indicate greater levels of fatigue.
Drexel University
Other
Evaluating a Remotely Delivered Behavioral Weight Loss Intervention Using an Ad Libitum Plant-Based Diet Versus a Balanced Calorie Deficit Diet
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.
Published trials that share one or more normalized conditions with this study.
NCT06584916
Body Weight, Body Weight Changes
Birmingham, Alabama, United States
View Trial DetailsNCT02736669
Behavior, Body Weight
Birmingham, Alabama, United States
View Trial DetailsNCT05056376
Behavior, Body Weight
Baltimore, Maryland, United States
View Trial DetailsNCT05981508
Behavior, Behavior, Animal
Chapel Hill, North Carolina, United States
View Trial Details