- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04242641
An Exploratory Study to Determine the Potential Impact of Parental Attendance at WW on Weight and Behavioural Outcomes in Children: WWChild (WWChild)
An Exploratory Study to Determine the Potential Impact of Parental Attendance at WW on Weight and Behavioural Outcomes in Children
Study Overview
Detailed 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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Yorkshire
-
Leeds, West Yorkshire, United Kingdom, LS2 9JT
- Clinical Trials Research Unit, University of Leeds
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Parent Inclusion Criteria:
- Male or female ages 18-75 years
- Body Mass Index (BMI) of 25 to 45 (confirmed at baseline by researcher measurement)
- Self report need to lose weight. Parent/primary care-giver to a child meeting child eligibility criteria
- Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by physician, with the exception of multivitamins or other vitamin supplement
- Willing to follow recommendations required by study protocol (2 appointments), including attending programme workshops and using App if assigned to the WW arm
- Use of a personal smartphone (iOS 9.0 or Android 4.1 or higher with at least 54MB of available storage for Android or 154 MB for iPhone to accommodate the size of the WW app)
- Residing within 30 miles of a WW workshop
- Ability to read, write and speak English at an adequate level to receive the intervention
Child Inclusion Criteria
- Must be at or over the 85th percentile (confirmed at baseline by researcher measurement)
- Must be aged between 5 and 11 years at baseline
- Must live with enrolled parent for the majority of the time
Parent Exclusion Criteria:
- Membership at WW within the past 12 months.
- Given birth in the past six months, currently pregnant, or planning on becoming pregnant over the next 3 months.
- Weight loss of ≥ 5 kg in the previous 6 months.
- History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months.
- Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.
- Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg (asked as 'high blood pressure in on-line/telephone screen; confirmed at baseline visit)
- Currently have type 1 or type II diabetes (pre-diabetes acceptable);
- Currently have chronic/inflammatory gastrointestinal disorder (irritable bowel syndrome acceptable)
- Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems)
- Taking any prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications such as Qysmia, Contrave, with the exception of those on a stable dose of SSRIs for at least 6 months
- Ever had surgical procedure for weight loss.
- Major surgery within the previous 12 months.
- Presence of implanted cardiac defibrillator or pacemaker.
- History of cancer within past 5 years or current treatment for cancer (if skin cancer, past 6 months)
- Currently have a medical diagnosis of Anorexia Nervosa or Bulimia Nervosa
- Hospitalisation for psychiatric problems during the past 12 months
- Planning to relocate in the next 12 months
- Another member (excluding the enrolled child) of the household is participating in this research study
Child Exclusion Criteria
- Currently enrolled in any weight loss related programmes
- Diagnosed with Prader- Willi syndrome, Cushing Syndrome, Hypothyroidism or Hashimoto's Disease.
- Weight loss of ≥ 5% in the previous 6 months.
- Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.
- Currently have type 1 or type II diabetes (pre-diabetes acceptable);
- Currently have chronic/inflammatory gastrointestinal disorder (irritable bowel syndrome acceptable)
- Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems)
- Taking any prescription medication with known effects on appetite or weight.
- Major surgery within the previous 12 months.
- Presence of implanted cardiac defibrillator or pacemaker.
- History of cancer within past 5 years or current treatment for cancer
- Hospitalisation for psychiatric problems during the past 12 months
Another child of the household is participating in this research study
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WW (formally Weight Watchers)
The intervention will consist of engaging with the WW programme for 12 weeks, including weekly attendance at a local WW workshop and access to digital tools.
Only the parent will take part in the WW intervention.
No modifications will be made to the current WW programme to support child weight loss.
|
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.
|
No Intervention: Control
Participants randomised to the control group will receive no intervention during the 3 month period.
Following final data collection control participants will receive 3 month complimentary access to WW.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment to online screener
Time Frame: Baseline
|
Number of individuals that self-refer to the WWChild online screener
|
Baseline
|
Number of eligible participant
Time Frame: Baseline
|
The number of eligible parent-child dyads that complete both the online and telephone screening process that determines eligibility.
|
Baseline
|
Number of non eligible participant dyads
Time Frame: Baseline
|
The number of dyads that complete both the online and telephone screener who are not eligible
|
Baseline
|
Reason for non-eligibility
Time Frame: Baseline
|
The number of participants who are ineligible for each reason for not being included in the study
|
Baseline
|
Number of participant dyads invited to baseline appointment
Time Frame: Baseline
|
The total number of participant dyads that are invited to attend a baseline appointment following online and telephone eligibility screening
|
Baseline
|
Number of baseline appointments completed
Time Frame: Baseline
|
The total number of participant dyads that complete baseline appointments
|
Baseline
|
Number of follow up appointments completed
Time Frame: 3 month follow up
|
The total number of participant dyads that complete a 3 month follow up data collection appointment
|
3 month follow up
|
Number of withdrawals
Time Frame: 3 month follow up
|
The total number of withdrawals from the study
|
3 month follow up
|
Time point of withdrawal
Time Frame: 3 month follow up
|
The time point within the study of withdrawals
|
3 month follow up
|
Reason for withdrawal
Time Frame: 3 month follow up
|
The number of participants that withdraw for each reason
|
3 month follow up
|
Number of parent height and weights collected
Time Frame: 3 month follow up
|
The total number of parent participants that have had both their height and weight measured.
|
3 month follow up
|
Number of child height and weights collected
Time Frame: 3 month follow up
|
The total number of child participants that have had both their height and weight collected
|
3 month follow up
|
Reason for non-completion of data collection protocol
Time Frame: 3 month follow up
|
The total number of participant dyads that have not had all data collected according to the protocol for each reason for non completion
|
3 month follow up
|
Trial acceptability qualitatively assessed through interviews with participants
Time Frame: 3 month follow up
|
Qualitative interviews with parents will assess the acceptability of the study.
|
3 month follow up
|
Compliance with WW intervention
Time Frame: 3 month follow up
|
Intervention attendance and usage of the intervention app will be analysed to measure compliance of intervention
|
3 month follow up
|
Reasons for participation
Time Frame: 3 month follow up
|
Qualitative interviews will be used to explore reasons for participation in the study and potential barriers.
|
3 month follow up
|
Testing of assumptions of parental attendance having potential to impact on child outcomes
Time Frame: 3 month follow up.
|
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.
|
3 month follow up.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in child BMI (Weight(kg)/ Height(m)²)z score
Time Frame: Baseline and 3 month follow up
|
Difference in BMI (Weight(kg)/Height(m)2) z-score change of child from baseline to follow up between groups randomised to receive WW intervention and group randomised to the control group at 3 month post randomisation.
|
Baseline and 3 month follow up
|
Differences in weight (kg) change of adult
Time Frame: Baseline and 3 month follow up
|
Differences in weight (kg) change of adult from baseline to follow up between intervention and control arm at 3 months post randomisation.
|
Baseline and 3 month follow up
|
Differences in weight (kg) change of child
Time Frame: Baseline and 3 month follow up
|
Differences in weight (kg) change of child from baseline to follow up between intervention and control arm at 3 months post randomisation.
|
Baseline and 3 month follow up
|
Difference in waist circumference (cm) of adult
Time Frame: Baseline and 3 month follow up
|
Difference in waist circumference (cm) of adult from baseline to follow up between intervention and control arm at 3 months post randomisation.
|
Baseline and 3 month follow up
|
Difference in waist circumference (cm) of child
Time Frame: Baseline and 3 month follow up
|
Difference in waist circumference (cm) of child from baseline to follow up between intervention and control arm at 3 months post randomisation.
|
Baseline and 3 month follow up
|
Fitness (sit to stand test) adult
Time Frame: Baseline and follow up
|
Difference in fitness measured by the total number of sit to stands completed in one minute from baseline to follow up between intervention and control arm
|
Baseline and follow up
|
Fitness (sit to stand test) child
Time Frame: Baseline and follow up
|
Difference in fitness measured by the total number of sit to stands completed in one minute from baseline to follow up between intervention and control arm at 3 months post randomisation
|
Baseline and follow up
|
Flexibility (sit and reach) adult
Time Frame: Baseline and follow up
|
Difference in flexibility measured by the distance reached during the sit and reach test from baseline to follow up between intervention and control arm at 3 month post randomisation
|
Baseline and follow up
|
Flexibility (sit and reach) child
Time Frame: Baseline and follow up
|
Difference in flexibility measured by the distance reached during the sit and reach test from baseline to follow up between intervention and control arm at 3 month post randomisation
|
Baseline and follow up
|
Parenting self-efficacy (via Dumka PSAM).
Time Frame: Baseline and follow up
|
Differences in parent self efficacy score based on the Dumka PSAM from baseline to follow up between intervention and control arm
|
Baseline and follow up
|
Family eating behaviours (via Golan Family Eating and Activity Habits Questionnaire).
Time Frame: Baseline and 3 month follow up
|
Difference in family eating behaviour scores based on the Golan Family Eating and Activity Habits Questionnaire from baseline to follow up between intervention and control arm.
|
Baseline and 3 month follow up
|
Self-efficacy of diet and exercise behaviours (Sallis 1988)
Time Frame: Baseline and 3 month follow up
|
Difference in parent self efficacy of diet and exercise behaviours from baseline to follow up between intervention and control arm.
|
Baseline and 3 month follow up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maria Bryant, PhD, Clinical Trials Research Unit, University of Leeds
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MREC 19-0.23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity, Childhood
-
Universiteit LeidenWageningen University; Nutricia, Inc.; Danone ResearchCompletedChildhood Obesity | Childhood Overweight | Vegetable Acceptance in Early ChildhoodNetherlands
-
Vanderbilt University Medical CenterActive, not recruitingPediatric Obesity | Childhood Obesity | Childhood Onset ObesityUnited States
-
Tehran University of Medical SciencesUnknownChildhood Obesity PreventionIran, Islamic Republic of
-
Oregon State UniversityCompletedChildhood Obesity Prevention
-
The Miriam HospitalHassenfeld Child Health Innovation InstituteCompletedChildhood Obesity PreventionUnited States
-
Fundacion para la Formacion e Investigacion Sanitarias...UnknownChildhood Obesity PreventionSpain
-
Tampere UniversitySeinajoki Central Hospital; Tampere University Hospital; Foundation for Paediatric... and other collaboratorsCompleted
-
Cornell UniversityCompletedChildhood Obesity Prevention
-
Harokopio UniversityCompletedPrevention of Childhood ObesityGreece
-
University of Alabama at BirminghamCompletedObesity, Childhood | Overweight, ChildhoodUnited States
Clinical Trials on WW
-
Cedars-Sinai Medical CenterCompleted
-
Georgia Southern UniversityIndiana University; Weight Watchers InternationalActive, not recruitingOverweight and ObesityUnited States
-
University of PennsylvaniaWeight Watchers InternationalCompleted
-
Medical University of South CarolinaWW InternationalCompletedObesity | Weight LossUnited States
-
Pennington Biomedical Research CenterWeight Watchers InternationalRecruitingObesity | Diabetes Mellitus | Type 2 DiabetesUnited States
-
Pennington Biomedical Research CenterWW International Inc.WithdrawnObesity | Diabetes Mellitus, Type 2United States
-
Pennington Biomedical Research CenterWW International Inc.CompletedOverweight and Obesity | Type2 DiabetesUnited States
-
Cedars-Sinai Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); The... and other collaboratorsRecruiting
-
Mid-Ohio Food CollectiveWeight Watchers InternationalCompletedFood Insecurity | Overweight and Obesity | Weight Change, Body | Produce PrescriptionUnited States
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingWeight Loss | Cardiovascular Risk Factor | Diet, HealthyUnited States