Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198744
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Brief Title:
Efficacy of Parent-Child Dieting Plans Incorporating Medifast Meal Replacements for Weight Loss
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-01
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:
None
Brief Summary:
1 Does a joint parent-child dieting approach as opposed to an individually-based approach improve weight loss outcomes
2 Is a diet which includes Medifast meal replacements as efficacious as a non-supplemented Food Guide Pyramid-based diet reference diet in achieving better adherence to the diet initial weight loss reduction in body fat and weight maintenance
3 Does regular use of Medifast meal replacements in conjunction with a Food Guide Pyramid-based diet result in significantly better compliance greater dietary satisfaction dietary quality and palatability than the reference diet
4 Do children who have lost weight using Medifast meal replacements as an adjunct to a Food Guide Pyramid-based diet achieve health benefits compared to baseline values and are these health benefits greater than those obtained following the reference diet
2 Is a diet which includes Medifast meal replacements as efficacious as a non-supplemented Food Guide Pyramid-based diet reference diet in achieving better adherence to the diet initial weight loss reduction in body fat and weight maintenance
3 Does regular use of Medifast meal replacements in conjunction with a Food Guide Pyramid-based diet result in significantly better compliance greater dietary satisfaction dietary quality and palatability than the reference diet
4 Do children who have lost weight using Medifast meal replacements as an adjunct to a Food Guide Pyramid-based diet achieve health benefits compared to baseline values and are these health benefits greater than those obtained following the reference diet
Detailed Description:
Weight Loss Phase This phase will take place between week 0 and week 26 6 months Participants will be randomly assigned to one of two weight loss treatment groups
1 Medifast meal replacement diet group 3 supplements per day plus food-based diet
2 Reference diet group Food Guide Pyramid-based diet
Participants will be further randomly assigned to one of two parent-child approaches
1 Dieting child with one dieting parent
2 Dieting child without dieting parent Although it is encouraged to have both parents involved in the childs care only one parent will be permitted to be dieting as a part of the study along with the child so that we can more cleanly assess the effects of a parent dieting without confounding effects of some families having two parents dieting Both groups will attend separate biweekly educational lessons during the weight loss phase same curriculum and teacher Data collection visits will occur at baseline week 12 and transition There are a total of 31 visits for a child participating in this study and 30for a parent participating by dieting with their child
Transition Phase Transition to a maintenance diet will be individually timed by participant attainment of goal healthy weight BMI 25 or week 26 whichever comes first
Maintenance Phase This phase will occur after completion of weight loss or between weeks 27 and 78 12 months Groups will attend separate educational lessons same curriculum and teacher once every 4 weeks The Medifast group will reduce supplements to 2 per day with a larger portion of calories from whole foods The reference diet group will remain on a food-based no supplements maintenance diet for the entire 52 week maintenance period Data collection visits will occur at weeks 26 and 52
1 Medifast meal replacement diet group 3 supplements per day plus food-based diet
2 Reference diet group Food Guide Pyramid-based diet
Participants will be further randomly assigned to one of two parent-child approaches
1 Dieting child with one dieting parent
2 Dieting child without dieting parent Although it is encouraged to have both parents involved in the childs care only one parent will be permitted to be dieting as a part of the study along with the child so that we can more cleanly assess the effects of a parent dieting without confounding effects of some families having two parents dieting Both groups will attend separate biweekly educational lessons during the weight loss phase same curriculum and teacher Data collection visits will occur at baseline week 12 and transition There are a total of 31 visits for a child participating in this study and 30for a parent participating by dieting with their child
Transition Phase Transition to a maintenance diet will be individually timed by participant attainment of goal healthy weight BMI 25 or week 26 whichever comes first
Maintenance Phase This phase will occur after completion of weight loss or between weeks 27 and 78 12 months Groups will attend separate educational lessons same curriculum and teacher once every 4 weeks The Medifast group will reduce supplements to 2 per day with a larger portion of calories from whole foods The reference diet group will remain on a food-based no supplements maintenance diet for the entire 52 week maintenance period Data collection visits will occur at weeks 26 and 52
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