Back to resultsAn Exploratory Study to Determine the Potential Impact of Parental Attendance at WW on Weight and Behavioural Outcomes in Children: WWChild (WWChild)
Primary Purpose
Obesity, Childhood
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
WW
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Childhood
Eligibility Criteria
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
-
Sites / Locations
- Clinical Trials Research Unit, University of Leeds
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
WW (formally Weight Watchers)
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Recruitment to online screener
Number of individuals that self-refer to the WWChild online screener
Number of eligible participant
The number of eligible parent-child dyads that complete both the online and telephone screening process that determines eligibility.
Number of non eligible participant dyads
The number of dyads that complete both the online and telephone screener who are not eligible
Reason for non-eligibility
The number of participants who are ineligible for each reason for not being included in the study
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
Number of baseline appointments completed
The total number of participant dyads that complete baseline appointments
Number of follow up appointments completed
The total number of participant dyads that complete a 3 month follow up data collection appointment
Number of withdrawals
The total number of withdrawals from the study
Time point of withdrawal
The time point within the study of withdrawals
Reason for withdrawal
The number of participants that withdraw for each reason
Number of parent height and weights collected
The total number of parent participants that have had both their height and weight measured.
Number of child height and weights collected
The total number of child participants that have had both their height and weight collected
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
Trial acceptability qualitatively assessed through interviews with participants
Qualitative interviews with parents will assess the acceptability of the study.
Compliance with WW intervention
Intervention attendance and usage of the intervention app will be analysed to measure compliance of intervention
Reasons for participation
Qualitative interviews will be used to explore reasons for participation in the study and potential barriers.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04242641
First Posted
January 17, 2020
Last Updated
August 25, 2021
Sponsor
University of Leeds
Collaborators
Weight Watchers International
1. Study Identification
Unique Protocol Identification Number
NCT04242641
Brief Title
An Exploratory Study to Determine the Potential Impact of Parental Attendance at WW on Weight and Behavioural Outcomes in Children: WWChild
Acronym
WWChild
Official Title
An Exploratory Study to Determine the Potential Impact of Parental Attendance at WW on Weight and Behavioural Outcomes in Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to Covid pandemic
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds
Collaborators
Weight Watchers International
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomised on a 1:1 ratio to either the intervention arm (WW programme) or to the control group.
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blinded to the which arm the participants have been allocated.
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WW (formally Weight Watchers)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
WW
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment to online screener
Description
Number of individuals that self-refer to the WWChild online screener
Time Frame
Baseline
Title
Number of eligible participant
Description
The number of eligible parent-child dyads that complete both the online and telephone screening process that determines eligibility.
Time Frame
Baseline
Title
Number of non eligible participant dyads
Description
The number of dyads that complete both the online and telephone screener who are not eligible
Time Frame
Baseline
Title
Reason for non-eligibility
Description
The number of participants who are ineligible for each reason for not being included in the study
Time Frame
Baseline
Title
Number of participant dyads invited to baseline appointment
Description
The total number of participant dyads that are invited to attend a baseline appointment following online and telephone eligibility screening
Time Frame
Baseline
Title
Number of baseline appointments completed
Description
The total number of participant dyads that complete baseline appointments
Time Frame
Baseline
Title
Number of follow up appointments completed
Description
The total number of participant dyads that complete a 3 month follow up data collection appointment
Time Frame
3 month follow up
Title
Number of withdrawals
Description
The total number of withdrawals from the study
Time Frame
3 month follow up
Title
Time point of withdrawal
Description
The time point within the study of withdrawals
Time Frame
3 month follow up
Title
Reason for withdrawal
Description
The number of participants that withdraw for each reason
Time Frame
3 month follow up
Title
Number of parent height and weights collected
Description
The total number of parent participants that have had both their height and weight measured.
Time Frame
3 month follow up
Title
Number of child height and weights collected
Description
The total number of child participants that have had both their height and weight collected
Time Frame
3 month follow up
Title
Reason for non-completion of data collection protocol
Description
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
Title
Trial acceptability qualitatively assessed through interviews with participants
Description
Qualitative interviews with parents will assess the acceptability of the study.
Time Frame
3 month follow up
Title
Compliance with WW intervention
Description
Intervention attendance and usage of the intervention app will be analysed to measure compliance of intervention
Time Frame
3 month follow up
Title
Reasons for participation
Description
Qualitative interviews will be used to explore reasons for participation in the study and potential barriers.
Time Frame
3 month follow up
Title
Testing of assumptions of parental attendance having potential to impact on child outcomes
Description
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.
Other Pre-specified Outcome Measures:
Title
Difference in child BMI (Weight(kg)/ Height(m)²)z score
Description
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.
Time Frame
Baseline and 3 month follow up
Title
Differences in weight (kg) change of adult
Description
Differences in weight (kg) change of adult from baseline to follow up between intervention and control arm at 3 months post randomisation.
Time Frame
Baseline and 3 month follow up
Title
Differences in weight (kg) change of child
Description
Differences in weight (kg) change of child from baseline to follow up between intervention and control arm at 3 months post randomisation.
Time Frame
Baseline and 3 month follow up
Title
Difference in waist circumference (cm) of adult
Description
Difference in waist circumference (cm) of adult from baseline to follow up between intervention and control arm at 3 months post randomisation.
Time Frame
Baseline and 3 month follow up
Title
Difference in waist circumference (cm) of child
Description
Difference in waist circumference (cm) of child from baseline to follow up between intervention and control arm at 3 months post randomisation.
Time Frame
Baseline and 3 month follow up
Title
Fitness (sit to stand test) adult
Description
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
Time Frame
Baseline and follow up
Title
Fitness (sit to stand test) child
Description
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
Time Frame
Baseline and follow up
Title
Flexibility (sit and reach) adult
Description
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
Time Frame
Baseline and follow up
Title
Flexibility (sit and reach) child
Description
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
Time Frame
Baseline and follow up
Title
Parenting self-efficacy (via Dumka PSAM).
Description
Differences in parent self efficacy score based on the Dumka PSAM from baseline to follow up between intervention and control arm
Time Frame
Baseline and follow up
Title
Family eating behaviours (via Golan Family Eating and Activity Habits Questionnaire).
Description
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.
Time Frame
Baseline and 3 month follow up
Title
Self-efficacy of diet and exercise behaviours (Sallis 1988)
Description
Difference in parent self efficacy of diet and exercise behaviours from baseline to follow up between intervention and control arm.
Time Frame
Baseline and 3 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Bryant, PhD
Organizational Affiliation
Clinical Trials Research Unit, University of Leeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trials Research Unit, University of Leeds
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS2 9JT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Exploratory Study to Determine the Potential Impact of Parental Attendance at WW on Weight and Behavioural Outcomes in Children: WWChild
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