Methods: Participants (9-11 years old) were recruited and randomized into 4 treatment groups (600 mg calcium, 12 g SCF, 12 g SCF plus 600 mg calcium and placebo). Interventions were consumed as a fruit-flavored powdered drink for 1-year. School-based recruitment was effective due to support on study benefits from parents and teachers, peer influence and a 2-weeks study run-in for participants to assess their readiness to commit to the study protocol. Retention strategies focused on building rapport through school-based fun activities, WhatsApp messaging, providing health screening and travel reimbursements for study measurements. Compliance was enhanced by providing direct on-site school feeding and monthly non-cash rewards. Choice of 2 flavors for the intervention drinks were provided to overcome taste fatigue. Satisfaction level on the manner in which the study was conducted was obtained from a voluntary sub-set of participants.
Results: The study successfully enrolled 243 participants within 6 months and retained 82.7% of the participants at the end of 1 year, yielding a drop-out rate of 17.3%. Compliance to the intervention drink was 85% at the start and remained at 78.7% at the end of 1 year. More than 95% of the participants provided good feedback on intervention drinks, rapport building activities, communication and overall study conduct.
Conclusion: Successful strategies focused on study benefits, rapport building, frequent communication using social media and non-cash incentives helped improved compliance and retention rate. The lessons learned to maintain a high retention and compliance rate in this study provide valuable insights for future studies in a similar population.
METHODS: Body composition, bone mineral density (BMD), and bone mineral content (BMC) at the lumbar spine (LS) and total body (TB) were assessed using dual-energy X-ray absorptiometry (DXA). Calcium intake was assessed using 1-week diet history, MET (metabolic equivalent of task) score using cPAQ physical activity questionnaire, and serum 25(OH) vitamin D using LC-MS/MS.
RESULTS: The mean calcium intake was 349 ± 180 mg/day and mean serum 25(OH)D level was 43.9 ± 14.5 nmol/L. In boys, lean mass (LM) was a significant predictor of LSBMC (β = 0.539, p
INTRODUCTION: SCF has been reported to improve calcium absorption. We investigated the long-term effect of SCF and calcium on bone indices of healthy preadolescent children aged 9-11 years old.
METHODS: In a double-blind, randomised, parallel arm study, 243 participants were randomised into four groups: placebo, 12-g SCF, 600-mg calcium lactate gluconate (Ca) and 12-g SCF + 600-mg calcium lactate gluconate (SCF + Ca). Total body bone mineral content (TBBMC) and total body bone mineral density (TBBMD) were measured using dual-energy X-ray absorptiometry at baseline, 6 and 12 months.
RESULTS: At 6 months, SCF + Ca had a significant increase in TBBMC from baseline (27.14 ± 6.10 g, p = 0.001). At 12 months, there was a significant increase in TBBMC from baseline in the SCF + Ca (40.28 ± 9.03 g, p = 0.001) and SCF groups (27.34 ± 7.93 g, p = 0.037). At 6 months, the change in TBBMD in the SCF + Ca (0.019 ± 0.003 g/cm2) and Ca (0.014 ± 0.003 g/cm2) groups was significantly different (p