Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330629
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2006-05-26
Brief Title:
Preference and Vegetarian Diet in Weight Loss Treatment
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Preference and Vegetarian Diet in Weight Loss Treatment
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREFER
Brief 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 Eligible respondents will be randomized to one of two conditions Treatment Preference-YesNo Individuals in the Treatment Preference-Yes will be assigned to their choice SBT or SBTLOV those in Treatment Preference-No will be randomized to either SBT or SBTLOV 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 Wing42-44 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 studies42 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 calorieswk
Behavioral Strategies to Use in Changing Eating and Exercise Habits The central features follow
Goal setting dailyweekly goals for calorie and fat consumption exercise time and behavior change
Self-monitoring systematically observing and recording ones behavior4546 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 activity10 Problem solving consists of 5 steps identifying the problem brainstorming solutions evaluating the proscons of each potential solution implementing the solution plan and evaluating its success4748 Social assertion use assertive skills in situations that may threaten their meeting eatingexercise goals
Feedback therapists monitor the recorded behavior changes and provide feedbackencouragement
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 eatingexercising develop problem-solving strategies50-53 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 ie overweightobesity at baseline rapid weight loss inadequate calorie and fat gram intake and guidelines for reducing risk for cholelithiasis ie 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
c62 Dietary Intervention The treatment conditions will differ in eating plans and breadth of content eg cooking classes grocery shopping field trips to better assist and support SBTLOV participants develop their skills to implement and maintain the vegetarian meal plan The differences are described below
c621 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
c622 Group 2 Dietary Intervention for the SBTLOV 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 intakeexpenditure 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 eg 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 patients physician if value is below normal The cost for this test will be covered by the grant
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 studies42 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 calorieswk
Behavioral Strategies to Use in Changing Eating and Exercise Habits The central features follow
Goal setting dailyweekly goals for calorie and fat consumption exercise time and behavior change
Self-monitoring systematically observing and recording ones behavior4546 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 activity10 Problem solving consists of 5 steps identifying the problem brainstorming solutions evaluating the proscons of each potential solution implementing the solution plan and evaluating its success4748 Social assertion use assertive skills in situations that may threaten their meeting eatingexercise goals
Feedback therapists monitor the recorded behavior changes and provide feedbackencouragement
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 eatingexercising develop problem-solving strategies50-53 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 ie overweightobesity at baseline rapid weight loss inadequate calorie and fat gram intake and guidelines for reducing risk for cholelithiasis ie 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
c62 Dietary Intervention The treatment conditions will differ in eating plans and breadth of content eg cooking classes grocery shopping field trips to better assist and support SBTLOV participants develop their skills to implement and maintain the vegetarian meal plan The differences are described below
c621 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
c622 Group 2 Dietary Intervention for the SBTLOV 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 intakeexpenditure 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 eg 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 patients physician if value is below normal The cost for this test will be covered by the grant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK058631 | NIH | None | httpsreporternihgovquickSearchR01DK058631 |