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| Name | Class |
|---|---|
| Medifast, Inc. | INDUSTRY |
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:
Participants will be further randomly assigned to one of two parent-child approaches:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medifast FIT! for Kids | Behavioral | |||
| standard recommendations for dietary intake in children | Behavioral | |||
| both diet plans with and without a parent dieting | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | ||
| BMI |
| Measure | Description | Time Frame |
|---|---|---|
| blood changes | ||
| body composition | ||
| psychometrics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence J Cheskin, MD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland | 21205 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004435 | Eating |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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