Condition category
Musculoskeletal Diseases
Date applied
02/05/2005
Date assigned
03/05/2005
Last edited
15/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Simone French

ORCID ID

Contact details

Division of Epidemiology
& Community Health
1300 S 2nd St
#300
Minneapolis
55454
United States of America
+1 612 626 8495
french@epi.umn.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R01 HD 037743

Study information

Scientific title

Acronym

Cal Girls

Study hypothesis

It was hypothesised that the behavioural intervention would result in increases in dietary Calcium (Ca) intake and weight-bearing physical activity (PA), and in the rate of bone mass accrual. Innovative aspects of the present study included:
1. Its focus on changing eating and PA behaviors to increase bone mass growth
2. Its focus on pre-adolescent girls, a group at risk for declines in Ca intake and PA levels as they develop into adolescence
3. Its unique collaboration with a community-based organisation (the Girl Scouts of America) as a channel to implement a health behaviour intervention

Ethics approval

The study was reviewed and approved by the University of Minnesota Research Participants Internal Review Board.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Osteoporosis prevention

Intervention

Thirty 5th-grade Girl Scout troops were recruited and randomised to a two-year behavioural intervention program (n = 15 troops) or to a no-treatment control group (n = 15 troops). The behavioural program was implemented during 5th and 6th grades by trained troop leaders as part of the regular troop meetings. The intervention program was based on Social Cognitive Theory and consisted of ten 90-minute activity-based sessions during each of the two years. It focused on the development of behavioural skills to choose Ca-rich foods and to engage in weight-bearing physical activity. Behavioural goals for the intervention were to
increase daily dietary Ca intake to 1300 mg/day (increase of 4 daily servings of Ca rich foods; about 800 Ca mg/day) and to increase weight-bearing physical activity to 120 minutes per week. A continuously available, interactive web-based program, and a one-week summer camp between 5th and 6th grade years, were implemented as components of the intervention program. Parents were also targeted through the web-based program.

Control troops did not receive any program and conducted their usual troop meeting activities during the two-year intervention period.

Evaluation was conducted with individual girls and a parent at clinic visits at baseline prior to randomisation, at one-year follow-up, and at the end of the study (two year follow-up).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change in areal bone mineral content (aBMC) was the primary outcome variable for the study because it best reflects bone mass change in developing children.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

01/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

30 5th-grade Girl Scout troops from the Minneapolis and St Paul metropolitan area were recruited to take part in the study through mailed fliers to troop leaders and troop leader meeting announcements. Troop eligibility criteria were:
1. Troop size greater than or equal to 8 girls
2. Parental consent and girl assent from each troop member to participate in troop meetings with intervention program activities
3. Troop plans to remain together at minimum two more years

Participant type

Patient

Age group

Child

Gender

Female

Target number of participants

322

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2003

Recruitment end date

01/01/2004

Locations

Countries of recruitment

United States of America

Trial participating centre

Division of Epidemiology
Minneapolis
55454
United States of America

Sponsor information

Organisation

University of Minnesota (USA)

Sponsor details

Division of Epidemiology
& Community Health
1300 S 2nd St
#300
Minneapolis
55454
United States of America
+1 612 624 1818
french@epi.umn.edu

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Insititutes of Health (NIH) (USA) (ref: R01 HD 037743)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16029507

Publication citations

  1. Results

    French SA, Story M, Fulkerson JA, Himes JH, Hannan P, Neumark-Sztainer D, Ensrud K, Increasing weight-bearing physical activity and calcium-rich foods to promote bone mass gains among 9-11 year old girls: outcomes of the Cal-Girls study., Int J Behav Nutr Phys Act, 2005, 2, 8, doi: 10.1186/1479-5868-2-8.

Additional files

Editorial Notes