Increasing weight-bearing physical activity and calcium-rich foods to promote bone mass gains among 9-11 year old girls: the Cal Girls study

ISRCTN ISRCTN74938765
DOI https://doi.org/10.1186/ISRCTN74938765
Secondary identifying numbers R01 HD 037743
Submission date
02/05/2005
Registration date
03/05/2005
Last edited
15/02/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Simone French
Scientific

Division of Epidemiology
& Community Health
1300 S 2nd St, #300
Minneapolis
55454
United States of America

Phone +1 612 626 8495
Email french@epi.umn.edu

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific title
Study acronymCal Girls
Study objectivesIt 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(s)The study was reviewed and approved by the University of Minnesota Research Participants Internal Review Board.
Health condition(s) or problem(s) studiedOsteoporosis prevention
InterventionThirty 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 typeOther
Primary outcome measureChange 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 measuresNot provided at time of registration
Overall study start date01/01/2003
Completion date01/01/2004

Eligibility

Participant type(s)Patient
Age groupChild
SexFemale
Target number of participants322
Key inclusion criteria30 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2003
Date of final enrolment01/01/2004

Locations

Countries of recruitment

  • United States of America

Study participating centre

Division of Epidemiology
Minneapolis
55454
United States of America

Sponsor information

University of Minnesota (USA)
University/education

Division of Epidemiology
& Community Health
1300 S 2nd St, #300
Minneapolis
55454
United States of America

Phone +1 612 624 1818
Email french@epi.umn.edu
ROR logo "ROR" https://ror.org/017zqws13

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 19/07/2005 Yes No