Adequate Dairy Intake on Weight Change in Girls (DQ)

Creighton University

Status

Completed

Conditions

Obesity

Treatments

Behavioral: counseling on increasing calcium intake

Other: observation

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01066806

07-14739

Details and patient eligibility

About

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.

Enrollment

274 patients

Sex

Female

Ages

13 to 14 years old

Volunteers

Accepts Healthy Volunteers

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