Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Obesity, Childhood
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be randomised on a 1:1 ratio to either the intervention arm (WW programme) or to the control group.Masking: Single (Outcomes Assessor)Masking Description: Outcome assessors will be blinded to the which arm the participants have been allocated.Primary Purpose: Treatment

Participation Requirements

Age
Between 5 years and 75 years
Gender
Both males and females

Description

Study objectives: To determine if it is possible to recruit parents who have a BMI ?25 with children whose BMI is over the 85th percentile and assess the recruitment rate. To assess the acceptability and feasibility of collecting height and weight data from both the parent and child during two asses...

Study objectives: To determine if it is possible to recruit parents who have a BMI ?25 with children whose BMI is over the 85th percentile and assess the recruitment rate. To assess the acceptability and feasibility of collecting height and weight data from both the parent and child during two assessment visits (baseline and follow-up). To explore trends and variance in outcomes between treatment allocation to support the utility of a future definitive trial and to develop a sample size calculation. To assess the acceptability and sensitivity of secondary outcome measures to evaluate the potential impact of parental attendance at WW on weight related behaviours of the family and child (eg. eating habits and physical activity levels). To test the assumptions in the logic model through which parental participation is assumed to impact on child outcomes (Programme Theory). WWChild is a randomised feasibility study with an embedded process evaluation, aiming to recruit 60 participants. Participants will be recruited through advertising using relevant channels that will target parents of children of primary school age. All eligible participants will be registered and allocated to either 3 month programme with WW or to a waiting list control arm. Participants initially randomised to the control arm will receive free access to 3 month programme with WW after follow up data has been collected. Children will not attend the WW sessions. Screening of participants will take place at multiple time-points. The initial screen will be conducted online by people who are interested in the study (self-referred). Those potentially meeting eligibility criteria will be asked to contact researchers at the Clinical Trials Research Unit by telephone or email, who will provide more information about the study and re-assess eligibility. If potentially eligible and interested, they will be invited to a baseline assessment visit, where eligibility will be confirmed, consent will be obtained, participants will be registered and baseline data will be collected. Participants will also be randomised at the end of this visit.

Tracking Information

NCT #
NCT04242641
Collaborators
WW International Inc.
Investigators
Principal Investigator: Maria Bryant, PhD Clinical Trials Research Unit, University of Leeds