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Trial of ?Families for Health?: helping families with children who are overweight to manage their weight

A randomised controlled trial evaluating the effectiveness and cost-effectiveness of ?Families for Health?, a family-based childhood obesity treatment intervention delivered in a community setting for ages 7 to 11

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN45032201
Enrollment
120
Registered
2011-08-18
Start date
2011-10-01
Completion date
Unknown
Last updated
2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood overweight and obesity Nutritional, Metabolic, Endocrine Obesity

Interventions

Families will be randomised to: 1. ?Families for Health? (60 families) 2. Control group receiving ?usual care? (60 families) Intervention arm: ?Families for Health? is a 10 week family-based interve

Sponsors

University of Warwick (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Families with at least one overweight (>91st centile for BMI) or obese (?very overweight?) (>98th centile for BMI) child aged 7-11 years 2. At least one parent/guardian and child willing to take part

Exclusion criteria

Exclusion criteria: 1. Parent or child with insufficient command of English, who would find it difficult to participate in the group 2. Metabolic or other recognised medical cause of obesity 3. Children with severe learning difficulties and/or behavioural problems

Design outcomes

Primary

MeasureTime frame
1. Change in children?'s BMI z-score at 12 months follow-up (change from baseline) (BMI (kg/m2) will be measured at baseline, 3 months and 12 months follow-up, and converted into standard deviation scores (z) from 1990 UK growth reference curves [Cole 1995])

Secondary

MeasureTime frame
Children?'s measurements at baseline, 3 and 12 months: 1. Waist circumference (z-score) 2. Percentage body fat 3. Habitual activity (7-day accelerometer recording) (not at 3 months) 4. Quality of life (PedsQL) (Varni 1998) 5. Fruit and vegetable consumption (Edmunds 2002) Parent?s' measurements at baseline, 3 and 12 months: 1. BMI 2. Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) (Tennant 2007) 3. Family eating and activity (Golan 1998) 4. Quality of parent-child relationships (Pianta 1992) 5. Parenting style (Robinson 2001) 6. Health state valuation (EQ-5D) (Dolan 1997) Economic evaluation: 1. Incremental cost per quality-adjusted life year (QALY) gained, estimated using responses to the EuroQol EQ-5D-Y health state valuation (youth version) (Ravens-Sieberer et al, 2010), costs to deliver the programme and questionnaire of costs to attend completed by parents 2. A de novo decision-analytic model will also be developed in order to estimate the lifetime clinical and economic consequences of the ?Families for Health? intervention, using established economic modelling techniques Process evaluation: 1. To investigate the parents? and children?s perceptions of the ?Families for Health? programme in Coventry, Warwickshire and Wolverhampton. Interviews will be carried out with up to 24 intervention group parents and their children at the end of the intervention and at 12 months 2. To investigate the fidelity of the implementation and delivery of the ?Families for Health? programme in Coventry, Warwickshire and Wolverhampton. Programme fidelity will be assessed using flip-charts used during the sessions, parents? weekly evaluation, facilitators? weekly log of delivery, and audio recorded discussions with facilitators for four sessions in each programme 3. Success of recruitment methods, attendance rates (number of sessions attended) and drop out rates will be recorded

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026