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Compare intermittent versus continuous calorie restriction to learn more about these eating plans and determine whether they are useful and effective to lose weight and keep it off.
The purpose of this study is to provide evidence for the feasibility of an alternative weight control strategy by comparing two diets to see how intermittent calorie restriction compares to continuous or daily calorie restriction for weight loss in 35 adults with overweight or obesity. These diets will be incorporated into a comprehensive and intensive weight management program involving weekly health education meetings, regular diet and physical activity tracking, and feedback from a registered dietitian.
Each intervention includes 3 months of weight loss and 3 months of weight maintenance.
Group 1: Follow a low-calorie diet every day (1,200 - 1,500 calories daily)
Group 2: Follow an intermittent very-low calorie diet (500-800 calories). Participants in this group will alternate between days of 500-800 calories and days of structured eating using healthy eating principles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Calorie Restriction | Active Comparator | Daily calorie restriction: follow low-calorie diet (1,200-1,500 calories) daily using portion-controlled meals |
|
| Intermittent Very-Low Calorie Diet | Experimental | Intermittent Restriction: follow very-low calorie diet (500-800) with portion-controlled meals three days per week and structured healthy eating on other days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portion-Controlled Meals | Dietary Supplement | Increase dietary structure using portion-controlled meals (PCM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight (lbs, % change from baseline) | Change in absolute (lbs) and relative (%) weight from baseline to the end of the intervention (24 weeks) | Change from baseline to 24 weeks |
| Body composition | Change in absolute (g) and relative (%) fat mass and fat-free mass from baseline to 24 weeks | Change from baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Program adherence | Compliance to intervention protocol; adherence = (# attained / # expected)*100 | weekly through study completion (24 weeks) |
| Nutrition-related quality of life | Assessed via questionnaire; higher scores indicate greater nutrition-related quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra Sullivan, PhD, RD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| Low-Calorie Diet | Behavioral | Restrict calorie intake daily |
|
| Intermittent Very-Low Calorie Diet | Behavioral | Severely restrict calorie intake intermittently |
|
|
| baseline, week 12, week 24 |
| Dietary restraint | Assessed via three-factor eating questionnaire with three component scores for cognitive restraint, disinhibition, hunger) | baseline, week 12, week 24 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |