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Study protocol: evaluation of 'JenMe', a commercially-delivered weight management program for adolescents: a randomised controlled trial.

Dordevic AL, Bonham MP, Ware RS, Brennan L, Truby H - BMC Public Health (2015)

Bottom Line: The commercial program will consist of a combined dietary and lifestyle approach targeting improved health behaviours for weight-loss or weight-stability.Secondary outcome measures will include changes in behaviour, physical activity and psychosocial wellbeing.Ethics approval has been granted from the Monash University Human Research Ethics Committee (CF11/3687-2011001940).

View Article: PubMed Central - PubMed

Affiliation: Department of Nutrition & Dietetics, Monash University, Level 1, 264 Ferntree Gully Rd, Notting Hill, VIC, 3168, Australia. aimee.dordevic@monash.edu.

ABSTRACT

Background: Early lifestyle intervention with overweight and obese adolescents could help to avoid serious health events in early adulthood, ultimately alleviating some of the strain on the public health system due to obesity-related morbidity. Commercial weight loss programs have wide reach into the community setting, and have demonstrated success in long term weight management in adults, beyond that of current public health care. Commercial weight-management programs have not been evaluated as a method of delivery for overweight and obese adolescents. This study aims to evaluate the efficacy of a new adolescent weight management program in a commercial environment.

Methods: One hundred and forty adolescents, 13 to 17 years old, will be randomised to either a weight management program intervention or a wait-listed group for 12 weeks. The commercial program will consist of a combined dietary and lifestyle approach targeting improved health behaviours for weight-loss or weight-stability. Participants will be overweight or obese (above the 85(th) percentile for BMI) and without existing co-morbidities. Outcome measures will be assessed at baseline and after 12 weeks. Primary outcome measures will be changes in BMI Z-score and waist-height ratio. Secondary outcome measures will include changes in behaviour, physical activity and psychosocial wellbeing. Intervention participants will be followed up at 6 months following completion of the initial program. Ethics approval has been granted from the Monash University Human Research Ethics Committee (CF11/3687-2011001940).

Discussion: This independent evaluation of a weight management program for adolescents, delivered in a commercial setting, will provide initial evidence for the effectiveness of such programs; which may offer adolescents an avenue of weight-management with ongoing support prior to the development of obesity related co-morbidities.

Trial registration: The protocol for this study is registered with the International Clinical Trials Registry ISRCTN13602313.

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Related in: MedlinePlus

Study flow design. One hundred and forty adolescents (13 to 17 years, BMI Z-score ≥ 1.282) will be recruited and randomised 1:1 to either the intervention or wait-listed control group. The intervention group will receive a 12 week commercial weight management program. The wait-listed control group will be offered the program after the control period (12 weeks)
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Fig1: Study flow design. One hundred and forty adolescents (13 to 17 years, BMI Z-score ≥ 1.282) will be recruited and randomised 1:1 to either the intervention or wait-listed control group. The intervention group will receive a 12 week commercial weight management program. The wait-listed control group will be offered the program after the control period (12 weeks)

Mentions: The current study is a multicentre, parallel-group randomised controlled trial. Adolescent boys and girls aged 13 to 17 years who apply to join the commercial weight management program will be screened for eligibility to participate. Individuals who do not meet the health screen requirement, a standard practice for enrolment to Jenny Craig weight management programs, will not be eligible for inclusion in the study. Exclusion criteria of the program include being aged less than 13 years or greater than 17 years; having diagnosed diabetes; being pregnant; having given birth to a child during adolescence; having a medical condition or using medications related to weight co-morbidities (except asthma). Individuals who have a BMI Z-score of ≥ 1.282, indicating that they are above the 85th percentile for BMI for their age and gender, will be invited to participate in the study. Participants will be randomised into either the treatment group or the wait-listed control group. The treatment group will enter the weight management program immediately, and the control group will be wait-listed for 12 weeks. Figure 1 shows the study flow. Behavioural questionnaires and diaries will be completed during the week prior to the first consultation where anthropometric characteristics of participants will be recorded. The same questionnaires and diaries will be repeated during week 12 (the final week of the program for participants in the interventions group), and participants will again have anthropometric characteristics recorded at the end of week 12. Primary outcome measures will include changes in BMI Z-score and waist to height ratio. Secondary outcome measures will include changes in physical activity levels, behaviour and psychosocial wellbeing. Participants will have the option to volunteer to have further cardio-metabolic risk factors and body composition examined. All experimental procedures are being conducted in accordance with the Declaration of Helsinki and were formally approved by the Monash University Human Research Ethics Committee (CF11/3687–2011001940).Fig. 1


Study protocol: evaluation of 'JenMe', a commercially-delivered weight management program for adolescents: a randomised controlled trial.

Dordevic AL, Bonham MP, Ware RS, Brennan L, Truby H - BMC Public Health (2015)

Study flow design. One hundred and forty adolescents (13 to 17 years, BMI Z-score ≥ 1.282) will be recruited and randomised 1:1 to either the intervention or wait-listed control group. The intervention group will receive a 12 week commercial weight management program. The wait-listed control group will be offered the program after the control period (12 weeks)
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4472172&req=5

Fig1: Study flow design. One hundred and forty adolescents (13 to 17 years, BMI Z-score ≥ 1.282) will be recruited and randomised 1:1 to either the intervention or wait-listed control group. The intervention group will receive a 12 week commercial weight management program. The wait-listed control group will be offered the program after the control period (12 weeks)
Mentions: The current study is a multicentre, parallel-group randomised controlled trial. Adolescent boys and girls aged 13 to 17 years who apply to join the commercial weight management program will be screened for eligibility to participate. Individuals who do not meet the health screen requirement, a standard practice for enrolment to Jenny Craig weight management programs, will not be eligible for inclusion in the study. Exclusion criteria of the program include being aged less than 13 years or greater than 17 years; having diagnosed diabetes; being pregnant; having given birth to a child during adolescence; having a medical condition or using medications related to weight co-morbidities (except asthma). Individuals who have a BMI Z-score of ≥ 1.282, indicating that they are above the 85th percentile for BMI for their age and gender, will be invited to participate in the study. Participants will be randomised into either the treatment group or the wait-listed control group. The treatment group will enter the weight management program immediately, and the control group will be wait-listed for 12 weeks. Figure 1 shows the study flow. Behavioural questionnaires and diaries will be completed during the week prior to the first consultation where anthropometric characteristics of participants will be recorded. The same questionnaires and diaries will be repeated during week 12 (the final week of the program for participants in the interventions group), and participants will again have anthropometric characteristics recorded at the end of week 12. Primary outcome measures will include changes in BMI Z-score and waist to height ratio. Secondary outcome measures will include changes in physical activity levels, behaviour and psychosocial wellbeing. Participants will have the option to volunteer to have further cardio-metabolic risk factors and body composition examined. All experimental procedures are being conducted in accordance with the Declaration of Helsinki and were formally approved by the Monash University Human Research Ethics Committee (CF11/3687–2011001940).Fig. 1

Bottom Line: The commercial program will consist of a combined dietary and lifestyle approach targeting improved health behaviours for weight-loss or weight-stability.Secondary outcome measures will include changes in behaviour, physical activity and psychosocial wellbeing.Ethics approval has been granted from the Monash University Human Research Ethics Committee (CF11/3687-2011001940).

View Article: PubMed Central - PubMed

Affiliation: Department of Nutrition & Dietetics, Monash University, Level 1, 264 Ferntree Gully Rd, Notting Hill, VIC, 3168, Australia. aimee.dordevic@monash.edu.

ABSTRACT

Background: Early lifestyle intervention with overweight and obese adolescents could help to avoid serious health events in early adulthood, ultimately alleviating some of the strain on the public health system due to obesity-related morbidity. Commercial weight loss programs have wide reach into the community setting, and have demonstrated success in long term weight management in adults, beyond that of current public health care. Commercial weight-management programs have not been evaluated as a method of delivery for overweight and obese adolescents. This study aims to evaluate the efficacy of a new adolescent weight management program in a commercial environment.

Methods: One hundred and forty adolescents, 13 to 17 years old, will be randomised to either a weight management program intervention or a wait-listed group for 12 weeks. The commercial program will consist of a combined dietary and lifestyle approach targeting improved health behaviours for weight-loss or weight-stability. Participants will be overweight or obese (above the 85(th) percentile for BMI) and without existing co-morbidities. Outcome measures will be assessed at baseline and after 12 weeks. Primary outcome measures will be changes in BMI Z-score and waist-height ratio. Secondary outcome measures will include changes in behaviour, physical activity and psychosocial wellbeing. Intervention participants will be followed up at 6 months following completion of the initial program. Ethics approval has been granted from the Monash University Human Research Ethics Committee (CF11/3687-2011001940).

Discussion: This independent evaluation of a weight management program for adolescents, delivered in a commercial setting, will provide initial evidence for the effectiveness of such programs; which may offer adolescents an avenue of weight-management with ongoing support prior to the development of obesity related co-morbidities.

Trial registration: The protocol for this study is registered with the International Clinical Trials Registry ISRCTN13602313.

Show MeSH
Related in: MedlinePlus