ObesityPREFERNCT00330629
Preference and Vegetarian Diet in Weight Loss Treatment
A study testing Standard Behavioral Treatment and SBT+LOV in people with Obesity and Overweight, run by University of Pittsburgh at 1 site in United States.
Trial summary
We propose to add a treatment preference component to a larger study testing standard behavioral treatment (SBT) for weight loss without specific food group restriction vs standard behavioral treatment with gradual elimination of meat, poultry, and fish [a lacto-ovo-vegetarian (LOV) meal plan]. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Standard Behavioral Treatment and SBT+LOV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Sep 2005
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- (1) be 18 to 55 years of age; (2) have a BMI of at least 27 but not greater than 43; (3) be willing to be randomized to one of the two preference conditions (Yes/No) and one of the two treatment conditions (SBT or SBT+LOV); and (4) have successfully completed a 5-day diary
Who cannot join
- (1) presence of a current serious illness or unstable condition (e.g., acute myocardial infarction or diabetes) for which physician supervision of diet and exercise prescription is needed; (2) presence of cardiovascular or orthopedic condition that would require physician clearance prior to participation; (3) limitations precluding ability to exercise; (4) pregnancy or intention to become pregnant in the next 18 months; (5) current treatment for a psychological disorder; (6) reported alcohol intake >4 drinks/day; (7) current or recent (past 6 months) participation in a weight loss treatment program or use of weight loss medication; (8) reporting no regular intake of meat, fish, and fowl; or presence of a serious binge eating problem
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, 15261
About this study
We propose to add a treatment preference component to a larger study testing standard behavioral treatment (SBT) for weight loss without specific food group restriction vs standard behavioral treatment with gradual elimination of meat, poultry, and fish [a lacto-ovo-vegetarian (LOV) meal plan]. Eligible respondents will be randomized to one of two conditions: Treatment Preference-Yes/No. Individuals in the Treatment Preference-Yes will be assigned to their choice (SBT or SBT+LOV), those in Treatment Preference-No will be randomized to either SBT or SBT+LOV without regard to their preference.
Read the detailed description
Both groups will receive the behavioral treatment program (32 sessions over 12 months) that has been used successfully in numerous behavioral weight loss studies conducted by Dr. Wing.42-44 The Treatment Preference-Yes and -No Groups will meet on separate evenings to avoid contamination across the conditions but will be led by the same multidisciplinary team (behavioral scientists, nutritionist, exercise physiologist). A brief description of elements common to both groups follows:
Group Sessions: Groups will meet for 45-60 minutes weekly for Months 1-6, bi-weekly for Months 7-9, and monthly for Months 10-12. Participants will be weighed, receive nutritional and behavioral counseling, turn in the weekly diaries, and receive homework assignments at the sessions.
Dietary Restrictions: Calorie Goal. Participants will receive an individualized calorie goal calculated from baseline body weight (1200 calories < 200 lbs; 1500 calories for > 200 lbs), used successfully in previous studies.42 Fat Goal. Fat gram goals will approximate 25% of calories.
Physical Activity and Exercise: Participants will gradually increase their exercise, primarily walking, until they reach a minimum goal of 150 minutes per week (a caloric expenditure of 1000 calories/wk).
Behavioral Strategies to Use in Changing Eating and Exercise Habits: The central features follow:
Goal setting: daily/weekly goals for calorie and fat consumption, exercise time, and behavior change.
Self-monitoring: systematically observing and recording one's behavior,45,46 which will be reviewed by the therapists, and written feedback will be provided to reinforce positive behaviors.
Stimulus control: behavioral strategies designed to assist participants in altering their environment, minimize the cues that might trigger problematic behaviors, and add cues to increase activity.10 Problem solving: consists of 5 steps: identifying the problem; brainstorming solutions; evaluating the pros/cons of each potential solution; implementing the solution plan; and evaluating its success.47,48 Social assertion: use assertive skills in situations that may threaten their meeting eating/exercise goals.
Feedback: therapists monitor the recorded behavior changes and provide feedback/encouragement.
Cognitive strategies: taught how to recognize patterns of negative thought that can interfere with behavior change, how to counter these negative thoughts, and to use positive self-statements.
Relapse prevention: recognize situations that place them at risk for lapses49 Maintenance: weight loss maintenance will be addressed, identify their own problems related to maintaining their new patterns of eating/exercising, develop problem-solving strategies.50-53 Reinforcement: provide a magazine subscription to reinforce what is learned in each group.
Ensuring dietary adequacy: diaries will be reviewed weekly for energy intake and expenditure and for nutrient adequacy. A dietitian will be part of the team reviewing the diaries.
Incentives: will be given a monetary incentive for completing the paper-and-pencil instruments, Three-Day Food Record, and appointment for phlebotomy at 6, 12, and 18 months, and for completing the Final Visit.
Educational Session on Risk of Cholelithiasis: A brief (~15-20 minutes with Questions and Answers to follow) educational session will be provided to study participants informing them of risk factors for cholelithiasis. The information presented will include predisposing risk factors (i.e., overweight/obesity at baseline, rapid weight loss, inadequate calorie and fat gram intake) and guidelines for reducing risk for cholelithiasis (i.e., safe rate of weekly weight loss, minimal caloric and fat gram intake per day). Participants will also be provided with an informational letter on cholelithisis risk factors and risk reduction and will be asked to sign this letter and return it to the staff on the project, to be placed in their study participant files.
c.6.2. Dietary Intervention The treatment conditions will differ in eating plans and breadth of content (e.g., cooking classes, grocery shopping field trips) to better assist and support SBT+LOV participants develop their skills to implement and maintain the vegetarian meal plan. The differences are described below.
c.6.2.1. Group 1: Dietary Intervention for the Standard Behavioral Treatment Group Participants in this condition will receive the standard behavioral treatment (SBT) described above. Food tastings will be held at the sessions and will focus on fat modified food products.
c.6.2.2. Group 2: Dietary Intervention for the SBT+LOV Group Diet: In addition to SBT, participants will aim to eliminate all meat, poultry, and fish from their diet over the first 6 weeks, and will be taught how to select appropriate substitutes for these foods, such as low- or no-fat dairy products (cheeses, milk), and protein-containing vegetable sources (soy products, legumes). The focus will be on the elimination of meat products as a means to reduce fat intake.
Self-monitoring: In addition to energy intake/expenditure, record the number of meat meals eaten.
Social support for dietary changes: One session will be offered: an overview of the eating pattern, how to merge different eating styles in one family, how to dine at the same restaurant, and how to attend family and social functions. Participants will be encouraged to bring family members. Family members will not be considered as subjects in the study and will not be asked to provide any information. They will be there as guests to receive information that may allow them to better support their family member who is participating in the study.
Modeling: Practicing vegetarians will share strategies on making the transition to a vegetarian diet.
Ensuring dietary adequacy: Menstruating females will be instructed to use vegetarian sources of iron (e.g., legumes, dark leafy greens, dried fruits) and to use iron supplements if their iron intake does not appear adequate on their reported diet. Hemoglobin will be measured at each assessment point and results will be reported to patient's physician if value is below normal. The cost for this test will be covered by the grant.
- Conditions
- Obesity, Overweight
- Being tested
- Standard Behavioral Treatment, SBT+LOV
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Behavioral TreatmentBehavioural
Participants in this condition will receive the standard behavioral treatment (SBT) described above. Food tastings will be held at the sessions and will focus on fat modified food products.
SBT+LOVBehavioural
The focus will be on the elimination of meat products as a means to reduce fat intake.
| Study group | Role | What they receive |
|---|---|---|
| Standard Behavioral Treatment | Active comparator | Goal setting: daily/weekly goals for calorie and fat consumption, exercise time, and behavior change.
Self-monitoring: systematically observing and recording one's behavior,45,46 which will be reviewed by the therapists, and written feedback will be provided to reinforce positive behaviors.
Feedback: therapists monitor the recorded behavior changes and provide feedback/encouragement. Receives: Behavioral: Standard Behavioral Treatment |
| SBT+LOV Group | Active comparator | In addition to SBT, participants will aim to eliminate all meat, poultry, and fish from their diet over the first 6 weeks, and will be taught how to select appropriate substitutes for these foods, such as low- or no-fat dairy products (cheeses, milk), and protein-containing vegetable sources (soy products, legumes). . Receives: Behavioral: Standard Behavioral Treatment; Behavioral: SBT+LOV |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change at 18 months
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startJan 2002
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lora Burke, University of Pittsburgh
- Investigators
- Lora E. Burke, PhD, MPH, RN, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330629
- Sponsor's protocol ID
- 000674
- Other IDs
- R01DK058631
- Acronym
- PREFER
- Status last verified
- Jul 2016
- First submitted
- 26 May 2006
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Goode RW, Ye L, Sereika SM, Zheng Y, Mattos M, Acharya SD, Ewing LJ, Danford C, Hu L, Imes CC, Chasens E, Osier N, Mancino J, Burke LE. Socio-demographic, anthropometric, and psychosocial predictors of attrition across behavioral weight-loss trials. Eat Behav. 2016 Jan;20:27-33. doi: 10.1016/j.eatbeh.2015.11.009. Epub 2015 Nov 14.
PubMed 26609668Warziski MT, Sereika SM, Styn MA, Music E, Burke LE. Changes in self-efficacy and dietary adherence: the impact on weight loss in the PREFER study. J Behav Med. 2008 Feb;31(1):81-92. doi: 10.1007/s10865-007-9135-2. Epub 2007 Oct 26.
PubMed 17963038Burke LE, Hudson AG, Warziski MT, Styn MA, Music E, Elci OU, Sereika SM. Effects of a vegetarian diet and treatment preference on biochemical and dietary variables in overweight and obese adults: a randomized clinical trial. Am J Clin Nutr. 2007 Sep;86(3):588-96. doi: 10.1093/ajcn/86.3.588.
PubMed 17823421
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preference and Vegetarian Diet in Weight Loss Treatment
- ClinicalTrials.gov ID
- NCT00330629
- Acronym / sponsor ID
- PREFER / 000674
- Conditions
- Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2002
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 29 May 2006 (estimated)
- 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.
We propose to add a treatment preference component to a larger study testing standard behavioral treatment (SBT) for weight loss without specific food group restriction vs standard behavioral treatment with gradual elimination of meat, poultry, and fish [a lacto-ovo-vegetarian (LOV) meal plan]. Eligible respondents will be randomized to one of two conditions: Treatment Preference-Yes/No. Individuals in the Treatment Preference-Yes will be assigned to their choice (SBT or SBT+LOV), those in Treatment Preference-No will be randomized to either SBT or SBT+LOV without regard to their preference.
Detailed description
Both groups will receive the behavioral treatment program (32 sessions over 12 months) that has been used successfully in numerous behavioral weight loss studies conducted by Dr. Wing.42-44 The Treatment Preference-Yes and -No Groups will meet on separate evenings to avoid contamination across the conditions but will be led by the same multidisciplinary team (behavioral scientists, nutritionist, exercise physiologist). A brief description of elements common to both groups follows:
Group Sessions: Groups will meet for 45-60 minutes weekly for Months 1-6, bi-weekly for Months 7-9, and monthly for Months 10-12. Participants will be weighed, receive nutritional and behavioral counseling, turn in the weekly diaries, and receive homework assignments at the sessions.
Dietary Restrictions: Calorie Goal. Participants will receive an individualized calorie goal calculated from baseline body weight (1200 calories < 200 lbs; 1500 calories for > 200 lbs), used successfully in previous studies.42 Fat Goal. Fat gram goals will approximate 25% of calories.
Physical Activity and Exercise: Participants will gradually increase their exercise, primarily walking, until they reach a minimum goal of 150 minutes per week (a caloric expenditure of 1000 calories/wk).
Behavioral Strategies to Use in Changing Eating and Exercise Habits: The central features follow:
Goal setting: daily/weekly goals for calorie and fat consumption, exercise time, and behavior change.
Self-monitoring: systematically observing and recording one's behavior,45,46 which will be reviewed by the therapists, and written feedback will be provided to reinforce positive behaviors.
Stimulus control: behavioral strategies designed to assist participants in altering their environment, minimize the cues that might trigger problematic behaviors, and add cues to increase activity.10 Problem solving: consists of 5 steps: identifying the problem; brainstorming solutions; evaluating the pros/cons of each potential solution; implementing the solution plan; and evaluating its success.47,48 Social assertion: use assertive skills in situations that may threaten their meeting eating/exercise goals.
Feedback: therapists monitor the recorded behavior changes and provide feedback/encouragement.
Cognitive strategies: taught how to recognize patterns of negative thought that can interfere with behavior change, how to counter these negative thoughts, and to use positive self-statements.
Relapse prevention: recognize situations that place them at risk for lapses49 Maintenance: weight loss maintenance will be addressed, identify their own problems related to maintaining their new patterns of eating/exercising, develop problem-solving strategies.50-53 Reinforcement: provide a magazine subscription to reinforce what is learned in each group.
Ensuring dietary adequacy: diaries will be reviewed weekly for energy intake and expenditure and for nutrient adequacy. A dietitian will be part of the team reviewing the diaries.
Incentives: will be given a monetary incentive for completing the paper-and-pencil instruments, Three-Day Food Record, and appointment for phlebotomy at 6, 12, and 18 months, and for completing the Final Visit.
Educational Session on Risk of Cholelithiasis: A brief (~15-20 minutes with Questions and Answers to follow) educational session will be provided to study participants informing them of risk factors for cholelithiasis. The information presented will include predisposing risk factors (i.e., overweight/obesity at baseline, rapid weight loss, inadequate calorie and fat gram intake) and guidelines for reducing risk for cholelithiasis (i.e., safe rate of weekly weight loss, minimal caloric and fat gram intake per day). Participants will also be provided with an informational letter on cholelithisis risk factors and risk reduction and will be asked to sign this letter and return it to the staff on the project, to be placed in their study participant files.
c.6.2. Dietary Intervention The treatment conditions will differ in eating plans and breadth of content (e.g., cooking classes, grocery shopping field trips) to better assist and support SBT+LOV participants develop their skills to implement and maintain the vegetarian meal plan. The differences are described below.
c.6.2.1. Group 1: Dietary Intervention for the Standard Behavioral Treatment Group Participants in this condition will receive the standard behavioral treatment (SBT) described above. Food tastings will be held at the sessions and will focus on fat modified food products.
c.6.2.2. Group 2: Dietary Intervention for the SBT+LOV Group Diet: In addition to SBT, participants will aim to eliminate all meat, poultry, and fish from their diet over the first 6 weeks, and will be taught how to select appropriate substitutes for these foods, such as low- or no-fat dairy products (cheeses, milk), and protein-containing vegetable sources (soy products, legumes). The focus will be on the elimination of meat products as a means to reduce fat intake.
Self-monitoring: In addition to energy intake/expenditure, record the number of meat meals eaten.
Social support for dietary changes: One session will be offered: an overview of the eating pattern, how to merge different eating styles in one family, how to dine at the same restaurant, and how to attend family and social functions. Participants will be encouraged to bring family members. Family members will not be considered as subjects in the study and will not be asked to provide any information. They will be there as guests to receive information that may allow them to better support their family member who is participating in the study.
Modeling: Practicing vegetarians will share strategies on making the transition to a vegetarian diet.
Ensuring dietary adequacy: Menstruating females will be instructed to use vegetarian sources of iron (e.g., legumes, dark leafy greens, dried fruits) and to use iron supplements if their iron intake does not appear adequate on their reported diet. Hemoglobin will be measured at each assessment point and results will be reported to patient's physician if value is below normal. The cost for this test will be covered by the grant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Behavioral Treatment | Active comparator | Behavioral: Standard Behavioral TreatmentGoal setting: daily/weekly goals for calorie and fat consumption, exercise time, and behavior change. Self-monitoring: systematically observing and recording one's behavior,45,46 which will be reviewed by the therapists, and written feedback will be provided to reinforce positive behaviors. Feedback: therapists monitor the recorded behavior changes and provide feedback/encouragement. |
| SBT+LOV Group | Active comparator | Behavioral: Standard Behavioral Treatment, Behavioral: SBT+LOVIn addition to SBT, participants will aim to eliminate all meat, poultry, and fish from their diet over the first 6 weeks, and will be taught how to select appropriate substitutes for these foods, such as low- or no-fat dairy products (cheeses, milk), and protein-containing vegetable sources (soy products, legumes). . |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (1) be 18 to 55 years of age; (2) have a BMI of at least 27 but not greater than 43; (3) be willing to be randomized to one of the two preference conditions (Yes/No) and one of the two treatment conditions (SBT or SBT+LOV); and (4) have successfully completed a 5-day diary
Key exclusion criteria (1 listed)
- (1) presence of a current serious illness or unstable condition (e.g., acute myocardial infarction or diabetes) for which physician supervision of diet and exercise prescription is needed; (2) presence of cardiovascular or orthopedic condition that would require physician clearance prior to participation; (3) limitations precluding ability to exercise; (4) pregnancy or intention to become pregnant in the next 18 months; (5) current treatment for a psychological disorder; (6) reported alcohol intake >4 drinks/day; (7) current or recent (past 6 months) participation in a weight loss treatment program or use of weight loss medication; (8) reporting no regular intake of meat, fish, and fowl; or presence of a serious binge eating problem
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 |
|---|---|---|
| Standard Behavioral TreatmentParticipants in this condition will receive the standard behavioral treatment (SBT) described above. Food tastings will be held at the sessions and will focus on fat modified food products. | Behavioural | SBT+LOV Group, Standard Behavioral Treatment |
| SBT+LOVThe focus will be on the elimination of meat products as a means to reduce fat intake. | Behavioural | SBT+LOV Group |
Primary outcome
weight change at 18 months
Time frame: 18 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 4 Jul 2016.
- Derived from this study: PubMed 26609668Goode RW, Ye L, Sereika SM, Zheng Y, Mattos M, Acharya SD, Ewing LJ, Danford C, Hu L, Imes CC, Chasens E, Osier N, Mancino J, Burke LE. Socio-demographic, anthropometric, and psychosocial predictors of attrition across behavioral weight-loss trials. Eat Behav. 2016 Jan;20:27-33. doi: 10.1016/j.eatbeh.2015.11.009. Epub 2015 Nov 14.
- Derived from this study: PubMed 17963038Warziski MT, Sereika SM, Styn MA, Music E, Burke LE. Changes in self-efficacy and dietary adherence: the impact on weight loss in the PREFER study. J Behav Med. 2008 Feb;31(1):81-92. doi: 10.1007/s10865-007-9135-2. Epub 2007 Oct 26.
- Derived from this study: PubMed 17823421Burke LE, Hudson AG, Warziski MT, Styn MA, Music E, Elci OU, Sereika SM. Effects of a vegetarian diet and treatment preference on biochemical and dietary variables in overweight and obese adults: a randomized clinical trial. Am J Clin Nutr. 2007 Sep;86(3):588-96. doi: 10.1093/ajcn/86.3.588.
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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.
Lora E. Burke, PhD, MPH, RN principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Behavioral Treatment and SBT+LOV in people with Obesity and Overweight, run by University of Pittsburgh 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 1 inclusion and 1 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 4 Jul 2016. 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 at 18 months (time frame: 18 months). 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 NCT00330629, which also lists 3 linked publications.
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 4 Jul 2016.