A family-centered lifestyle intervention to improve body composition and bone mass in overweight and obese children 6 through 8 years: a randomized controlled trial study protocol

Table 1 The MYLIFE study design: assessment and scheduling of baseline, follow-up visits and intervention sessions

	Baseline	3-mo			6-mo			9-mo			12-mo
Blood sampled ^a	●	●			●			●			●
Anthropometry ^b	●	●			●			●			●
Body composition assessment
DXA ^c
Whole-body	●	●			●			●			●
Bone assessments
DXA ^d
Whole-body	●	●			●			●			●
Lumbar spine vertebrae 1-4 (AP and AP-Lateral)	●				●						●
Total hip	●				●						●
Forearm (1/3 distal radius)	●				●						●
pQCT ^e
Radius (%: 4, 66)	●				●						●
Tibia (%: 4, 14, 38, 66)	●				●						●
Muscle function ^f	●	●			●			●			●
Questionnaires
Family Health (FHQ)	●
Child Health (CHQ)	●	●			●			●			●
Child Intention (CIQ)	●	●			●			●			●
Baseline education ^g	●	● ^h			● ^h			● ^h			● ^h
Interventions
Lifestyle intervention	End of Mo	1	2	3	4	5	6	7	8	9	10	11	12
Intervention groups		●	●	●	●	●			●
Control group ⁱ													●

^a Includes: Glucose, HbA1C, insulin, calcium, CBC-profile, lipid-profile, AST/ ALT, C-reactive protein, Estradiol, LH.
^b Includes: Weight, height, BMI, waist circumference, blood pressure, pulse and skin pigmentation by spectrophotometer (CM-700d/600d, Konica Minolta, Ramsey, NJ, USA).
^c Body composition assessed by DXA to yield: total mass (g), fat mass (g), lean + BMC (g) % BF, Android/ Gynoid ratio.
^d DXA measures of bone to yield: bone area (cm²), BMC (g), BMD (g/cm³).
^e pQCT measures both bone content [i.e. cortical density (mg/cm³)] and geometry [i.e. cortical area (mm²)].
^f Force plate assessment: jumping (force, power), sit-to-stand (force, power) and balance.
^g Basic Education: Performed by a registered dietitian; a basic review of nutrition and PA guide.
^h A dietitian is always present to answer questions and deal with age changes if in control.
ⁱ Control group receives the 6 lifestyle interventions after completion of 12 mo of study.