HELP trial: Healthy Eating Lifestyle Programme for adolescents

Completed

• Conditions: Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases; Nutritional, Metabolic, Endocrine; Obesity

• Registration Number: ISRCTN99840111
• Lead Sponsor: Institute of Child Health (ICH) (UK)

Brief Summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22088133 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28687677 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29449292

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-21
• Study Completion: 2014-09-01
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

Current inclusion criteria as of 13/07/2012:
1. Young people aged 12 - 19 years, either sex
2. Obese (body mass index [BMI] greater than 95th centile for age and sex)

Previous inclusion criteria until 13/07/2012:
1. Young people aged 13 - 17 years, either sex
2. Obese (body mass index [BMI] greater than International Obesity Task Force [IOTF] thresholds for age and sex)

Exclusion Criteria

Current exclusion criteria:
1. Participants with significant mental health problems or undergoing mental health treatment
2. Other chronic illness, known secondary obesity, monogenic obesity syndrome or use of medications known to promote obesity. Added 06/10/2015: Young people with asthma will be included in the study so long as they have not had more than one course of oral steroids in the preceding 3 months (where course is less than or equal to 5 days), or are on more than the first starting dose of inhaled steroids as per British Thoracic Society Guidelines.
3. Participants with significant learning disability
4. Participants with lack of command of English sufficient to render them unable to participate effectively in the planned intervention. The great majority of eligible young people from black or minority ethnic groups in this population have good command of English. Given the importance of standardising the intervention, it will not be possible to use interpreters to enable parents with poor English to participate. To allow as many young people as possible to participate while maintaining the external validity of the study, we will allowing another relative with good English to participate alongside the young person (if they wish it).
5. Participation in behavioural weight management programmes in the past 12 months. This does not include participation in commercial programmes such as Weight Watchers.
6. Young people with BMI greater than or equal to 45 kg/m2. We exclude this group as the evidence suggests they are unlikely to benefit from a community based intervention such as HELP.

Previous exclusion criteria until 13/07/2012:
6. Young people with BMI greater than or equal to 40 kg/m2. We exclude this group as the evidence suggests they are unlikely to benefit from a community based intervention such as HELP.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BMI (kg/m2), measured at 0, 13, 26, 52 weeks (follow-up assessment)