An Exploratory Study to Determine the Potential Impact of Parental Attendance at WW on Weight and Behavioural Outcomes in Children: WWChild

NCT04242641 | Terminated

• 1 other identifier: MREC 19-0.23
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (17)

• Recruitment to online screener

  Number of individuals that self-refer to the WWChild online screener

  Baseline

• Number of eligible participant

  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

  The number of dyads that complete both the online and telephone screener who are not eligible

  Baseline

• Reason for non-eligibility

  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

  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

  The total number of participant dyads that complete baseline appointments

  Baseline

• Number of follow up appointments completed

  The total number of participant dyads that complete a 3 month follow up data collection appointment

  3 month follow up

• Number of withdrawals

  The total number of withdrawals from the study

  3 month follow up

• Time point of withdrawal

  The time point within the study of withdrawals

  3 month follow up

• Reason for withdrawal

  The number of participants that withdraw for each reason

  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.

  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

  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

  3 month follow up

• Trial acceptability qualitatively assessed through interviews with participants

  Qualitative interviews with parents will assess the acceptability of the study.

  3 month follow up

• Compliance with WW intervention

  Intervention attendance and usage of the intervention app will be analysed to measure compliance of intervention

  3 month follow up

• Reasons for participation

  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

  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 Outcomes (12)

• Difference in child BMI (Weight(kg)/ Height(m)²)z score

  Baseline and 3 month follow up

• Differences in weight (kg) change of adult

  Baseline and 3 month follow up

• Differences in weight (kg) change of child

  Baseline and 3 month follow up

Study Arms (2)

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.

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.

Interventions

WW BEHAVIORAL

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.

WW (formally Weight Watchers)

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leeds: lead
• WW International Inc: collaborator

Study Sites (1)

Clinical Trials Research Unit, University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Bryant, PhD

  Clinical Trials Research Unit, University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to the which arm the participants have been allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomised on a 1:1 ratio to either the intervention arm (WW programme) or to the control group.

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 27, 2020
• Study Start: January 24, 2020
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)