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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HD033064 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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We are conducting an intervention study to examine the effects of a 16-week exercise and diet interventions on prevention of disease, specifically type 2 diabetes and heart disease, in Latino youth. Eighty overweight Latino boys and girls will be recruited and placed in one of the following intervention groups: 1) Control Group (delayed intervention), 2) Dietary Education Group (nutrition education focused on reducing sugar & soda, increased fiber & whole grain intake), 3) Combination of Strength Training (twice/week for 60 min, progressive increases in exercise volume and intensity) + Dietary Education (nutrition education focused on reducing sugar & soda, increased fiber & whole grain intake) or 4) Combination of Circuit Training (twice/week for 60 min, aerobic + strength training exercises) + Dietary Education (same as above). We will assess which intervention group has the most effects on health parameters such as weight, body composition, and insulin related measures.
The overall historical goal of this grant has been to examine the determinants of insulin resistance in children, especially the role of total fat and visceral fat during pubertal development in "high risk" minority children. Our previous longitudinal work has provided the platform to propose a new intervention phase of this research. This new emphasis is justified based on the magnitude of the pediatric obesity problem, particularly in susceptible ethnic groups, and the need to design and test novel interventions to reduce not just obesity, but the profound insulin resistance that we have observed in overweight minority children. Insulin resistance is thought to be central (and perhaps causative) to several metabolic abnormalities associated with type 2 diabetes and cardiovascular disease. Thus, interventions aimed at improving insulin resistance in susceptible children could be an effective means in the primary prevention of type 2 diabetes and cardiovascular disease.
The overall objective of this proposal is therefore to conduct a randomized controlled study to examine the effects of 16-week exercise and diet interventions on insulin sensitivity, insulin secretion, beta-cell function, and body fat distribution. Overweight Hispanic boys and girls (n=80) will be recruited and randomized to one of the following interventions:
Ø Control (delayed intervention) Ø Modification of carbohydrate intake (reduced sugar & soda, increased fiber & whole grain intake) using an individualized healthy exchange system and motivational interviewing Ø Strength training + modification of carbohydrate intake Ø Circuit Training + modification of carbohydrate intake
This study will provide new information on the effects of these interventions on primary outcomes at the level of body composition (total lean and fat mass, visceral fat, intramyocellular fat and liver fat) and insulin related measures (insulin secretion & sensitivity and beta-cell function). The hypotheses are:
The overall rationale for these interventions is based on three main factors. First, preliminary data are presented in overweight Hispanic boys showing that 16-weeks of strength training significantly improves insulin sensitivity in the absence of a reduction in total body fat and in the absence of any dietary intervention. Second, preliminary data suggests that overweight Hispanic children consume high levels of simple sugar, and low levels of fiber and complex carbohydrates, and data from the literature suggests that modification of carbohydrate consumption (reduced sugar, increased fiber & whole grain) can improve glucose control independent of body composition. Third we provide new preliminary data showing that the only dietary variable associated with insulin dynamics in overweight Hispanic children was high sugar intake which was associated with poor beta-cell function.
We have chosen to focus on Hispanic children because they are an understudied, high-risk population, and display significant obesity-related metabolic abnormalities probably emanating from profound insulin resistance (see preliminary data). In support of the feasibility of our proposal, we have developed extensive expertise in recruiting and retaining research volunteers from the large Hispanic population of East Los Angeles, we have an experienced multi-disciplinary group of investigators, and the University of Southern California has the necessary clinical research infrastructure to tackle this project. If our hypotheses are borne out, it will provide evidence for the incorporation of strength training and more specific and individualized dietary recommendations in the prevention and management of obesity, type 2 diabetes, and cardiovascular risk in overweight Hispanic youth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Control (C) | |
| 2 | Experimental | Nutrition (N) |
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| 3 | Experimental | Strength Training & Nutrition (ST + N) |
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| 4 | Experimental | Circuit Training & Nutrition (CT + N) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition | Behavioral | Nutrition classes for 1 hour & 30 minutes once a week for 16 weeks + motivational interviewing (4 individual sessions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| insulin sensitivity | post intervention (week 16) |
| Measure | Description | Time Frame |
|---|---|---|
| adiposity | post-intervention (week 16) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael I Goran, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veronica Atkins Lifestyle Intervention Laboratory | Los Angeles | California | 90033-9073 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23836520 | Derived | Gyllenhammer LE, Alderete TL, Mahurka S, Allayee H, Goran MI. Adipose tissue 11betaHSD1 gene expression, betacell function and ectopic fat in obese African Americans versus Hispanics. Obesity (Silver Spring). 2014 Jan;22(1):14-8. doi: 10.1002/oby.20571. Epub 2013 Sep 10. | |
| 23818490 | Derived | Hasson RE, Adam TC, Davis JN, Watanabe RM, Goran MI. Compensatory responses to insulin resistance in obese African-American and Latina girls. Pediatr Obes. 2013 Dec;8(6):e68-73. doi: 10.1111/j.2047-6310.2013.00184.x. Epub 2013 Jul 2. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| D055070 | Resistance Training |
| D065327 | Circuit-Based Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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| Strength Training & Nutrition | Behavioral | Strength Training twice a week for 1 hour a day for 16 weeks + Nutrition once a week for 1 hour & 30 minutes for 16 weeks + motivational interviewing (4 individual & 4 group sessions) |
|
| Circuit Training & Nutrition | Behavioral | Circuit Training twice a week for 1 hour a day for 16 weeks + Nutrition once a week for 1 hour & 30 minutes for 16 weeks + motivational interviewing (4 individual & 4 group sessions) |
|
| 22025778 | Derived | Le KA, Mahurkar S, Alderete TL, Hasson RE, Adam TC, Kim JS, Beale E, Xie C, Greenberg AS, Allayee H, Goran MI. Subcutaneous adipose tissue macrophage infiltration is associated with hepatic and visceral fat deposition, hyperinsulinemia, and stimulation of NF-kappaB stress pathway. Diabetes. 2011 Nov;60(11):2802-9. doi: 10.2337/db10-1263. |
| 21270204 | Derived | Le KA, Ventura EE, Fisher JQ, Davis JN, Weigensberg MJ, Punyanitya M, Hu HH, Nayak KS, Goran MI. Ethnic differences in pancreatic fat accumulation and its relationship with other fat depots and inflammatory markers. Diabetes Care. 2011 Feb;34(2):485-90. doi: 10.2337/dc10-0760. |
| 20962157 | Derived | Davis JN, Le KA, Walker RW, Vikman S, Spruijt-Metz D, Weigensberg MJ, Allayee H, Goran MI. Increased hepatic fat in overweight Hispanic youth influenced by interaction between genetic variation in PNPLA3 and high dietary carbohydrate and sugar consumption. Am J Clin Nutr. 2010 Dec;92(6):1522-7. doi: 10.3945/ajcn.2010.30185. Epub 2010 Oct 20. |
| 19349560 | Derived | Ventura E, Davis J, Byrd-Williams C, Alexander K, McClain A, Lane CJ, Spruijt-Metz D, Weigensberg M, Goran M. Reduction in risk factors for type 2 diabetes mellitus in response to a low-sugar, high-fiber dietary intervention in overweight Latino adolescents. Arch Pediatr Adolesc Med. 2009 Apr;163(4):320-7. doi: 10.1001/archpediatrics.2009.11. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |