Table 2 Basic characteristics of the included studies.
Characteristic | Fanti-Oren et al. [41] | Daley et al. [42] | ||
---|---|---|---|---|
Type of the study | Study described as randomised, controlled, double-blind with parallel-groups | Study described as randomised, controlled, double-blind with parallel-groups | Study described as randomised (block randomisation), controlled, double-blind | Study described as randomised, controlled. |
Number of individuals | N = 20 | N = 48 | N = 287 (n = 200 in total in placebo and control/ no-intervention group) | N = 81 (n = 53 in total in placebo and control group) |
Age, mean ± SD [years] | 10.43 ± 2.09^ | Excess body weight (overweight + obesity): 10.35 ± 2.12 Normal body weight: 9.78 ± 1.65 | Placebo: 8.18 ± 1.01 Control: 8.29 ± 1.04 | 13.1 (no data on SD) |
Sex | n = 7 girls n = 13 boys | Excess body weight (overweight + obesity): n = 10 girls; n = 14 boys; Normal body weight: n = 12 girls; n = 12 boys | Placebo: n = 50 girls, n = 50 boys Control: n = 50 girls, n = 50 boys | No data |
BMI status | Children with obesity (BMI ≥ 95 percentile) | Children with normal weight (BMI percentile ≥ 5 and < 85), overweight (BMI percentile ≥ 85 and < 95) and obesity (BMI percentile ≥ 95) | Z-score of 0 to −3 SD for height-for-age and weight-for-age | Adolescents with a BMI that exceeded the 98th percentile for age and sex |
Inclusion criteria | -pre-pubertal (Tanner stage 1) children; -children with obesity; -consent of parents/legal guardians | -pre-pubertal (Tanner stage 1) children; -consent of parents/ legal guardians | -written informed consent from the parents/legal guardians and participants | -written, informed consent; -BMI that exceeded the 98th percentile for age and sex according to 1990 United Kingdom reference data |
Exclusion criteria | -organic disease; -medications that might interfere with growth, weight control, or exercise tolerance (e.g., corticosteroids, thyroid hormone substitution, and recombinant growth hormone). | -organic disease; -medications that might interfere with growth, weight control, or exercise tolerance (e.g., corticosteroids, thyroid hormone substitution, and recombinant growth hormone). | -severe anemia (Hb 0.80 g × L21), cardiovascular or respiratory disease, physical disability, recent history of serious infections, or surgery or injuries that would impair their ability to perform the study tests; -individuals who were already taking nutritional supplements, if they had participated in a nutrition intervention study in the preceding year, or if they were family members of staff employed at the study site or with the sponsor | -medical conditions that would restrict the ability to be active 3 times per week for 8 weeks; -unwillingness to attend supervised exercise sessions 3 times per week for 8 weeks; -major cognitive or psychiatric impairments; -diagnosis of insulin-dependent diabetes mellitus or oral steroid treatment |
Placebo and control intervention | Before each testing session, the participants drank a glass of a drink: -placebo: the drink was described by the examiner as a drink that increases energy levels, strengthens muscles, and is therefore likely to improve exercise performance; the bottles were opaque, blue-coloured, and included a label proclaiming the content to be an energy drink that strengthens muscles and improves athletic performance; -control: the participants were informed that they are drinking water; the bottles were standard, transparent water bottles. | Before each testing session, the participants drank a glass of a drink: -placebo: the drink was described by the examiner as a drink that increases energy levels, strengthens muscles, and is therefore likely to improve exercise performance; the bottles were opaque, blue-coloured and included a label proclaiming the content to be an energy drink that strengthens muscles and improves athletic performance; -control: the participants were informed that they are drinking water; the bottles were standard, transparent water bottles. | Placebo group was administered an unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single servings of 40 g in 100 mL water. Administration once a day for 4 months under supervision of study personnel on all school days (6 days per week) and for self-consumption at weekends and/ or on holidays. Control group received no intervention. | Placebo: instead of aerobic exercise, participants performed light body-conditioning/stretching exercises, during which HR was maintained at 40% of HR reserve, and no exercise counselling or behavioural change advice was given. Control (usual care): participants were asked to continue with their lives as normal. |
Duration of the study | The participants were tested twice – once with water and once with placebo drink, in random order. | The participants were tested twice – once with water and once with placebo drink, in random order. | 120 days | After participants completed their 8-week interventions, they were given an individualised home exercise or body conditioning program (in line with their group assignments) to follow on their own for an additional 6 weeks (14-week follow-up period) |
End points of interest | -heart rate (initial and maximal), measured using Polar H10 heart rate monitor; - recovery time, measured as the time from the end of exercise until heart rate reached 100 bpm; -rate of perceived exertion (RPE), evaluated using the Borg scale -duration of ergometry phase | -heart rate (initial and maximal), measured using Polar H10 heart rate monitor; -recovery time, measured as the time from the end of exercise until heart rate reached 100 bpm; -rate of perceived exertion (RPE), evaluated using the Borg scale -duration of ergometry phase | -maximal aerobic capacity (VO2max) - defined as the maximum rate of oxygen consumption, measured during incremental exercise (externally placed 12-inch step test); -aerobic capacity(VO2peak) - defined as maximum rate of oxygen consumption attained on a particular exercise test (20 m shuttle run test); -40 m sprint was used to assess speed with time taken to complete the sprint being recorded manually using a digital stopwatch; -maximal handgrip strength for dominant and non-dominant hand, measured using Jamar hand dynamometer; -time to fatigue, defined as the time in seconds taken for the handgrip to fall from maximal value to 50% of the maximal value; -rate of decline of muscle strength was assessed to measure the muscle endurance of forearm; sustained isometric contraction of forearm flexors to 50% of maximal handgrip was measured using the Jamar hand dynamometer and was performed on the non-dominant arm. | -the poorly fit category of the modified Balke protocol was used to assess fitness (distance walked was recorded as a result); -resting heart rate |
Participants lost to follow-up/ who discontinued the study | All of the participants completed the study. | All of the participants completed the study. | 13 participants did not complete the study, of whom 2 were lost to follow-up and 11 withdrew consent (including in n = 4 placebo and n = 2 in control) | 7 participants lost to follow-up (1/23 in placebo and 5/30 in control group). |
Baseline values for the endpoints of interest | N.D. | N.D. | Placebo (N = 95), mean ± SD: -VO2max: 37.9 ± 5.6; -VO2peak: 32.8 ± 4.1; -40-meter sprint [s]: 8.9 ± 1.0; -maximal handgrip strength (dominant hand) [kg]: 9.4 ± 3.7; - maximal handgrip strength (non-dominant hand) [kg]: 8.6 ± 3.5; -time to fatigue in handgrip strength test [s]: 12.36 ± 7.66; -decline of muscle strength [kg/s]: 0.38 ± 0.24. Control (N = 97), mean ± SD: -VO2max: 37.0 ± 5.3; -VO2peak: 32.4 ± 4.2; -40 meter sprint [s]: 8.9 ± 1.0; -maximal handgrip strength (dominant hand) [kg]: 9.8 ± 3.4; -maximal handgrip strength (non-dominant hand) [kg]: 8.5 ± 3.2; -time to fatigue in handgrip strength test [s]: 11.13 ± 9.85; -decline of muscle strength [kg/s]: 0.42 ± 0.26. | Placebo (N = 95), mean ± SD: -resting heart rate [bpm]: 82.26 ± 8.30; -aerobic function [miles]: 0.36 ± 0.10; Control (N = 95), mean ± SD: -resting heart rate [bpm]: 84.62 ± 10.57; -aerobic function [miles]: 0.38 ± 0.12; |
Final follow-up values for the end points of interest | Placebo (N = 20), mean ± SD: -initial heart rate (bpm): 104.6 ± 12.8; -ergometry phase: 5.1 ± 1.2*; -running time [s]: 559.9 ± 151.0; -maximal heart rate (bpm): 176.1 ± 13.7*; -peak RPE: 18.0 ± 1.1; -average RPE: 12.1 ± 2.3*; -recovery time (s) 119.2 ± 25.3* Control (N = 20), mean ± SD: -initial heart rate (bpm): 104.2 ± 11.6; -ergometry phase: 3.9 ± 1.2; -running time (s): 434.4 ± 140.3; -maximal heart rate (bpm): 167.5 ± 16.8; -peak RPE: 19.1 ± 1.5; -average RPE: 13.6 ± 2.1; -recovery time (s)133.2 ± 23.7 | Placebo (N = 20), mean ± SD: -excess body weight (obesity+overweight): -initial heart rate (bpm): 103.8 ± 11.8; -ergometry phase: 4.8 ± 1.4*; -running time (s): 521.5 ± 182.5*; -maximal heart rate (bpm): 174.2 ± 14.8*; -peak RPE: 17.9 ± 1.7*; -average RPE: 12.5 ± 2.5*; - ecovery time (s)118.4 ± 31.6*; -normal body weight: -initial heart rate (bpm): 95.0 ± 7.6*; -ergometry phase: 7.6 ± 1.3*; -running time (s): 893.3 ± 150.1*; -maximal heart rate (bpm): 189.8 ± 12.2*; -peak RPE: 16.2 ± 1.5*; -average RPE: 10.7 ± 1.5*; -recovery time (s)96.7 ± 17.8*; Control (N = 20), mean ± SD: - excess body weight (obesity+overweight): -initial heart rate (bpm): 103.8 ± 11.8; -ergometry phase: 3.6 ± 1.4; -running time (s): 396.9 ± 161.9; -maximal heart rate (bpm): 165.8 ± 16.7; -peak RPE: 19.2 ± 1.0; -average RPE:14.1 ± 2.5; -recovery time (s)132.2 ± 28.5; -normal body weight: -initial heart rate (bpm): 94.8 ± 7.4; -ergometry phase: 6.0 ± 1.3; -running time (s): 700.1 ± 155.2; -maximal heart rate (bpm): 177.9 ± 13.6; -peak RPE: 18.3 ± 1.4; -average RPE: 12.1 ± 1.4; -recovery time (s)106.7 ± 18.6. | Placebo (N = 95), mean ± SD: -VO2max: 37.6 ± 5.3; -VO2peak: 38.6 ± 3.7; -40 meter sprint [s]: 8.9 ± 1.0; -maximal handgrip strength (dominant hand) [kg]: 10.6 ± 3.0; -maximal handgrip strength (non-dominant hand) [kg]: 9.5 ± 3.0; -time to fatigue in handgrip strength test [s]: 14.62 ± 6.35; -decline of muscle strength [kg/s]: 0.33 ± 0.16. Control (N = 97), mean ± SD: -VO2max: 37.8 ± 5.3; -VO2peak: 38.2 ± 4.2; -40 meter sprint [s]: 8.7 ± 1.0; -maximal handgrip strength (dominant hand) [kg]: 10.9 ± 3.2; - maximal handgrip strength (non-dominant hand) [kg]: 9.6 ± 2.6; -time to fatigue in handgrip strength test [s]: 14.03 ± 7.25; -decline of muscle strength [kg/s]: 0.35 ± 0.16. | Placebo (N = 95), mean ± SD: -resting heart rate [bpm]: 80.24 ± 1.01; -aerobic function [miles]: 0.37 ± 0.01; Control (N = 95), mean ± SD: -resting heart rate [bpm]: 81.12 ± 1.10; -aerobic function [miles]: 0.36 ± 0.01; |