NCT02581813

Brief Summary

The purpose of this study is to examine whether increased dairy intake, at the level recommended by Canada's Food Guide, combined with healthy eating and exercise, will improve body composition and bone turnover over 12 weeks in overweight and obese girls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

2.4 years

First QC Date

October 13, 2015

Last Update Submit

December 20, 2019

Conditions

OverweightObesityChildren

Keywords

Bone healthBody compositionDairy foodsExerciseinflammationnutrition interventionweight management

Outcome Measures

Primary Outcomes (3)

  • Change in lean mass

    body composition: lean mass (kg)

    3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

  • Change in fat mass

    body composition: fat mass (kg)

    3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

  • Change in % body fat

    body composition: % body fat

    3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

Secondary Outcomes (12)

  • Change in TNF-α

    3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

  • Change in IL-6 and IL-1β

    3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

  • Change in Leptin

    3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

  • Change in Adiponectin

    3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

  • Change in lipids

    3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

  • +7 more secondary outcomes

Study Arms (3)

RDa (Recommended dairy group)

EXPERIMENTAL

4 servings of dairy per day + exercise (3 times per week with combination of aerobic and resistance exercise).

Behavioral: I.D.E.A.L. for Adolescents Study - Higher Dairy

LDa (Low dairy group)

EXPERIMENTAL

0-1 serving of dairy per day + exercise (the same as the RDa group)

Behavioral: I.D.E.A.L. for Adolescents Study - Lower Dairy

GCon (growth controls)

NO INTERVENTION

This no-intervention group will serve as the control to account for growth during the study.

Interventions

I.D.E.A.L. for Adolescents Study - Higher DairyBEHAVIORAL

12 weeks diet and exercise intervention characterized by higher dairy consumption (4 servings per day) and exercise 3 times per week

RDa (Recommended dairy group)
I.D.E.A.L. for Adolescents Study - Lower DairyBEHAVIORAL

12 weeks diet and exercise intervention characterized by lower dairy consumption (0-1 serving per day) and exercise 3 times per week

LDa (Low dairy group)

Eligibility Criteria

Age10 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • at or above the age appropriate cut-offs for overweight (OW) or obese (OB) on WHO growth charts: ≥85-97% for OW and \>97% for OB for BMI
  • between 10 and 18 years old
  • menarcheal
  • low dairy consumers (0-2 svgs/d and \<700 mg Ca/d measured by baseline FFQ)
  • otherwise healthy (i.e. no diagnosed disease or illness)
  • lower levels of physical activity (0-2 times/week)
  • no allergy to dairy foods or diagnosed lactose intolerance
  • not on medications related to a chronic condition or that affect bone health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brock University

St. Catharines, Ontario, L2S3A1, Canada

Location

MeSH Terms

Conditions

OverweightObesityMotor ActivityInflammation

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorPathologic Processes

Study Officials

  • Andrea Josse, PhD

    Brock University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Kinesiology

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 21, 2015

Study Start

May 1, 2016

Primary Completion

October 1, 2018

Study Completion

May 1, 2019

Last Updated

December 24, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)