Obesity, ChildhoodWWChildNCT04242641
An Exploratory Study to Determine the Potential Impact of Parental Attendance at WW on Weight and Behavioural Outcomes in Children: WWChild
A study testing WW in people with Obesity, Childhood, run by University of Leeds at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- WW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jan 2020to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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 -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Trials Research Unit, University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
Official title: An Exploratory Study to Determine the Potential Impact of Parental Attendance at WW on Weight and Behavioural Outcomes in Children
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.
Read the 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.
- Conditions
- Obesity, Childhood
- Being tested
- WW
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WWBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| WW (formally Weight Watchers) | Experimental | 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. Receives: Behavioral: WW |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Recruitment to online screener
Number of individuals that self-refer to the WWChild online screener
Measured: Baseline
Number of eligible participant
The number of eligible parent-child dyads that complete both the online and telephone screening process that determines eligibility.
Measured: Baseline
Number of non eligible participant dyads
The number of dyads that complete both the online and telephone screener who are not eligible
Measured: Baseline
Reason for non-eligibility
The number of participants who are ineligible for each reason for not being included in the study
Measured: 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
Measured: Baseline
Number of baseline appointments completed
The total number of participant dyads that complete baseline appointments
Measured: Baseline
Number of follow up appointments completed
The total number of participant dyads that complete a 3 month follow up data collection appointment
Measured: 3 month follow up
Number of withdrawals
The total number of withdrawals from the study
Measured: 3 month follow up
Time point of withdrawal
The time point within the study of withdrawals
Measured: 3 month follow up
Reason for withdrawal
The number of participants that withdraw for each reason
Measured: 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.
Measured: 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
Measured: 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
Measured: 3 month follow up
Trial acceptability qualitatively assessed through interviews with participants
Qualitative interviews with parents will assess the acceptability of the study.
Measured: 3 month follow up
Compliance with WW intervention
Intervention attendance and usage of the intervention app will be analysed to measure compliance of intervention
Measured: 3 month follow up
Reasons for participation
Qualitative interviews will be used to explore reasons for participation in the study and potential barriers.
Measured: 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.
Measured: 3 month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start24 Jan 2020
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: Due to Covid pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- WW International Inc
- Responsible party
- Principal investigator, Maria Bryant, University of Leeds
- Investigators
- Maria Bryant, PhD, Principal investigator, Clinical Trials Research Unit, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242641
- Sponsor's protocol ID
- MREC 19-0.23
- Acronym
- WWChild
- Status last verified
- Aug 2021
- First submitted
- 17 Jan 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Determine the Potential Impact of Parental Attendance at WW on Weight and Behavioural Outcomes in Children
- ClinicalTrials.gov ID
- NCT04242641
- Acronym / sponsor ID
- WWChild / MREC 19-0.23
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Covid pandemic
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- WW International Inc
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomised on a 1:1 ratio to either the intervention arm (WW programme) or to the control group.
| Arm | Type | Receives |
|---|---|---|
| WW (formally Weight Watchers) | Experimental | Behavioral: WWThe 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WWWW 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. | Behavioural | WW (formally Weight Watchers) |
Primary outcome
Recruitment to online screener
Time frame: Baseline
Number of individuals that self-refer to the WWChild online screener
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.
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
Reason for non-eligibility
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: Baseline
The total number of participant dyads that complete baseline appointments
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
Number of withdrawals
Time frame: 3 month follow up
The total number of withdrawals from the study
Time point of withdrawal
Time frame: 3 month follow up
The time point within the study of withdrawals
Reason for withdrawal
Time frame: 3 month follow up
The number of participants that withdraw for each reason
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.
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
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
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.
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
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.
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.
Results and safety
The study was stopped early (reason given: Due to Covid pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Bryant, PhD principal investigator
Clinical Trials Research Unit, University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WW in people with Obesity, Childhood, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to Covid pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment to online screener (time frame: Baseline). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.