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
-
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.