The purpose of the WWChild study is to determine the feasibility of assessing the potential impact of parents attendance at WW on their child's weight status and weight related behaviours. The feasibility study will randomly allocate 60 parent participants to either the WW programme (formally Weight Watchers) or to a control arm. Data will be collected from both parent and child at baseline and at three months to explore changes in weight status and weight related behaviours.
Study objectives: 1. 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. 2. 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). 3. 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. 4. 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). 5. 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.
Study Type
INTERVENTIONAL
WW is a structured lifestyle modification, weight-loss programme involving a programme for healthy eating, physical activity and positive mindset and support via attendance at local WW workshops and digital tools.
Clinical Trials Research Unit, University of Leeds
Leeds, West Yorkshire, United Kingdom
Recruitment to online screener
Number of individuals that self-refer to the WWChild online screener
Time frame: Baseline
Number of eligible participant
The number of eligible parent-child dyads that complete both the online and telephone screening process that determines eligibility.
Time frame: Baseline
Number of non eligible participant dyads
The number of dyads that complete both the online and telephone screener who are not eligible
Time frame: Baseline
Reason for non-eligibility
The number of participants who are ineligible for each reason for not being included in the study
Time frame: Baseline
Number of participant dyads invited to baseline appointment
The total number of participant dyads that are invited to attend a baseline appointment following online and telephone eligibility screening
Time frame: Baseline
Number of baseline appointments completed
The total number of participant dyads that complete baseline appointments
Time frame: Baseline
Number of follow up appointments completed
The total number of participant dyads that complete a 3 month follow up data collection appointment
Time frame: 3 month follow up
Number of withdrawals
The total number of withdrawals from the study
Time frame: 3 month follow up
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Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2
Time point of withdrawal
The time point within the study of withdrawals
Time frame: 3 month follow up
Reason for withdrawal
The number of participants that withdraw for each reason
Time frame: 3 month follow up
Number of parent height and weights collected
The total number of parent participants that have had both their height and weight measured.
Time frame: 3 month follow up
Number of child height and weights collected
The total number of child participants that have had both their height and weight collected
Time frame: 3 month follow up
Reason for non-completion of data collection protocol
The total number of participant dyads that have not had all data collected according to the protocol for each reason for non completion
Time frame: 3 month follow up
Trial acceptability qualitatively assessed through interviews with participants
Qualitative interviews with parents will assess the acceptability of the study.
Time frame: 3 month follow up
Compliance with WW intervention
Intervention attendance and usage of the intervention app will be analysed to measure compliance of intervention
Time frame: 3 month follow up
Reasons for participation
Qualitative interviews will be used to explore reasons for participation in the study and potential barriers.
Time frame: 3 month follow up
Testing of assumptions of parental attendance having potential to impact on child outcomes
Qualitative interviews will be used to explore assumptions proposed in the logic model that proposes parental attendance at WW has the potential to impact on child outcomes.
Time frame: 3 month follow up.