Adequate Dairy Intake on Weight Change in Girls

Study Overview
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Brief Summary
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SPECIFIC AIM The aim of this study is to determine if increasing calcium intake to recommended levels with dairy foods in adolescent females with habitually low calcium intake and above-the-median body mass index (BMI) for sex and age will decrease body fat gain compared to similar females who continue their low calcium intake. . HYPOTHESIS Post-menarcheal adolescent girls with habitually low calcium intake who consume dairy foods providing at least 1200 mg of calcium per day will have a smaller increase in percent body fat, as measured by dual energy absorptiometry, during one year than post-menarcheal adolescent girls on a usual diet of 600 mg of calcium per day or less.

Official Title
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Efficacy of Optimal Levels of Dietary Dairy on Modulation of Adolescent Weight

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: counseling on increasing calcium intake
* Other: observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 13-14 years old (must be this age when consent is signed) Above the 50th percentile for BMI Above the 85th percentile for BMI with approval from their primary physician At least one and one- half years post menarche Habitual dietary calcium intake of 600mg/d or less as assessed by 3 day diet diary. This will be inclusive of supplemental calcium and dietary intake. Willingness to increase dietary calcium (low fat [skim, 1%, 2%] milk or yogurt) for one year Exclusion Criteria: Menarche prior to age 10 History of lactose intolerance or milk allergy Weight >300 pounds BMI > 97 percentile for age and gender Pregnancy Chronic disease or disorder like diabetes, polycystic ovarian syndrome, thyroid disease, seizures or cancer (cancer is ok if it has been >10 years) Use of steroids like prednisone, prednisolone, hydrocortisone, Flovent, Advair, or Nasonex Use of weight reducing medications like Meredia, alli, Dexatrim or Xenical Use of contraceptives like Yasmin, Ortho Tri-Cyclen, Apri, Aviane or Depo-Provera for any reason, including acne (see inclusive list) Use of acne medications like Accutane or high dose Vitamin A Use of ADHD medications like Adderall, Ritalin, Concerta. (Per Dr. Ramaswamy-Straterra OK) (see inclusive list) Use of seizure medications like Lamictal or Phenobarb (see inclusive list) Use of anti-depressants like Prozac or Effexor (see inclusive list) Diagnosed eating disorder Dieting behavior with weight loss > 10 pounds in the last 3 months (IF YES, consult with Project Manager) Metal in the skeleton (pins, rods, etc) Sibling of a child who is or has been on a dietary study in the last 5 years Total body BMC Z-score below -2.0 at baseline Participating in other ongoing research protocols

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high calcium diet<br> | Behavioral: counseling on increasing calcium intake<br>* The American Academy of Pediatrics recommends that adolescents ingest at least four servings of dairy food and at least 1300 mg calcium per day.<br>|
| Active Comparator: normal calcium diet<br> | Other: observation<br>* observe normal dairy intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent change in body fat |  | 1 year |