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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT000525-01 | U.S. NIH Grant/Contract | View source | |
| 1R01AT001930 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This study will examine the effects of a low carbohydrate diet versus a high carbohydrate diet on weight loss.
The number of overweight and obese Americans has increased significantly in recent years. There are now many different diet plans being promoted by doctors and the media. The Atkins diet, a low carbohydrate nutritional plan, is especially popular; its advocates claim that following the diet will result in long-term weight loss with no negative effects. Another diet, called the Dietary Approaches to Stop Hypertension (DASH) diet, is a high carbohydrate diet designed to help treat and prevent high blood pressure. However, more thorough investigation of these claims is needed. This study will compare the short- and long-term effects of the Atkins diet to the (DASH) diet. This trial will enroll overweight and obese participants.
This study will last 30 months and will comprise two phases. Participants will be randomly assigned to either the Atkins or DASH diet for 30 months. During Phase 1, all participants will undergo 6 months of weekly group therapy to encourage weight loss. Phase 2 is a weight loss maintenance phase. During Phase 2, participants will have monthly meetings with a therapist for weight loss support. Study visits will occur at study entry and at Months 3 and 30. At each study visit, weight measurements, blood and urine collection, and x-rays will occur to determine participants' weight loss, cardiovascular health, kidney function, and bone density.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atkins Diet | Experimental | Participants randomized to this arm will consume a low carbohydrate diet as described by Dr. Robert Atkins in his book: Dr. Atkins' New Diet Revolution New York: Avon Books, 2002. |
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| DASH Diet | Active Comparator | Participants randomized to this arm will consume the Dietary Approaches to Stop Hypertension (DASH) diet as described here: http://www.nhlbi.nih.gov/health/public/heart/hbp/dash/new\_dash.pdf |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atkins diet (low carbohydrate diet) | Behavioral |
| ||
| DASH diet (high carbohydrate diet) |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Excess weight loss (greater than 5 pounds a week)would trigger patient assessment. | monthly |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of cardiovascular disease | Elevated lipids or rising blood pressure during six month safety assessments would trigger additional participant evaluation | Every six months |
| bone health | end of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Njeri Karanja, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Center for Health Research | Portland | Oregon | 97227 | United States |
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| Behavioral |
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| kidney function | every six months |
| neuroendocrine mechanisms of hunger and satiety | end of study |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D006973 | Hypertension |
| D015431 | Weight Loss |
| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| D000076107 | Diet, High-Protein Low-Carbohydrate |
| D050528 | Diet, Carbohydrate-Restricted |
| D000073601 | Dietary Approaches To Stop Hypertension |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D000073600 | Diet, High-Protein |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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