Adequate Dairy Intake on Weight Change in Girls

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: counseling on increasing calcium intake; Other: observation

• Registration Number: NCT01066806
• Lead Sponsor: Creighton University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-21
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 274

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high calcium diet	counseling on increasing calcium intake	-
normal calcium diet	observation	-

Primary Outcome Measures

Name	Time	Method
percent change in body fat	1 year

Trial Locations

Locations (1)

Creighton University Medical Center, Osteoporosis Research Center; 🇺🇸 Omaha, Nebraska, United States