Srivastav 2021.

Study name	Structured, multifactorial randomized controlled intervention to investigate physical activity levels, body composition and diet in obese and overweight adolescents
Methods	Study design: cluster‐RCT Country: India
Participants	Overweight and obese male and female adolescents aged 11–16 years Inclusion criteria:  a. male and female; b. 11‐15 years; c. attending schools; d. BMI > 85th percentile on standard CDC control BMI for age growth; e. clear screening using PAR‐Q+. Exclusion criteria: a. diagnosed obesity due to metabolic, endocrine or medications; b. unable to attend weekly sessions in schools; c. diagnosed unsafe for participation by paediatrician or GP; d. involved in another structured exercise programme. Stated purpose: to compare the effectiveness of an exercise and dietary intervention that is culturally appropriate and school‐based to that of an exercise‐only intervention
Interventions	Intervention: Intervention 1: multifactorial intervention (MI) The multifactorial (MI) group A will include PA, diet education for the adolescent and parent education about healthy eating and PA/exercise. A qualified dietitian and physiotherapists will develop a manual educating student and their parents about healthy diet and optimum PA for the adolescent age group. The adolescents in the MI group will be given exercise, according to ACSM guidelines, for 60 min for 2 days a week during the physical therapy (PT) classes under the supervision of a physiotherapist and physical education teacher. Participants will also be educated about the importance of regular PA and healthy eating pattern verbally in the educational session at the beginning of the intervention of the programme. Educational awareness programmes will be conducted for the parents, and after the programme. Intervention 2: exercise (EX) Group B (EX) participants will be given exercise only for 45 min during PT classes under the supervision of a physiotherapist and physical education teacher. The same procedures as for group A will be followed but with no dietary education or behaviour change advice. Control: No intervention: (group C control (CON) participants will be encouraged to continue their regular daily activities and dietary pattern. They will also be reassessed post‐study and at follow‐up points. No nutritional education will be provided to the parents in group C).
Outcomes	Participants'outcomes of interest for this review Mental health symptoms – Short Moods and Feeling Questionnaire (SMFQ) Quality of life – Paediatrics Quality of Life Teen Report (PedsQL) Economic outcomes Nil Time points: baseline, post‐intervention (immediate post‐intervention, 3, 6 and 12 months follow‐up)
Starting date	1 May 2019 (first enrolment)
Contact information	Prateek Srivastav, prateek.srivastav@manipal.edu
Notes	Source of funding: not declared Prospective trial registration number: CTRI/2019/04/018834