Clinical trial NCT04242641: An Exploratory Study to Determine the Potential Impact of Parental Attendance at WW on Weight and Behavioural Outcomes in Children: 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
Overall status: TERMINATED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: WW International Inc
First posted: 2020-01-27
Enrollment: 2
Sex: ALL
Minimum age (years): 5
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised on a 1:1 ratio to either the intervention arm (WW programme) or to the control group.
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: Parent Inclusion Criteria:

1. Male or female ages 18-75 years
2. Body Mass Index (BMI) of 25 to 45 (confirmed at baseline by researcher measurement)
3. Self report need to lose weight. Parent/primary care-giver to a child meeting child eligibility criteria
4. Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by physician, with the exception of multivitamins or other vitamin supplement
5. Willing to follow recommendations required by study protocol (2 appointments), including attending programme workshops and using App if assigned to the WW arm
6. 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)
7. Residing within 30 miles of a WW workshop
8. Ability to read, write and speak English at an adequate level to receive the intervention

Child Inclusion Criteria

1. Must be at or over the 85th percentile (confirmed at baseline by researcher measurement)
2. Must be aged between 5 and 11 years at baseline
3. Must live with enrolled parent for the majority of the time

Parent Exclusion Criteria:

1. Membership at WW within the past 12 months.
2. Given birth in the past six months, currently pregnant, or planning on becoming pregnant over the next 3 months.
3. Weight loss of ≥ 5 kg in the previous 6 months.
4. History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months.
5. Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.
6. 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)
7. Currently have type 1 or type II diabetes (pre-diabetes acceptable);
8. Currently have chronic/inflammatory gastrointestinal disorder (irritable bowel syndrome acceptable)
9. Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems)
10. 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
11. Ever had surgical procedure for weight loss.
12. Major surgery within the previous 12 months.
13. Presence of implanted cardiac defibrillator or pacemaker.
14. History of cancer within past 5 years or current treatment for cancer (if skin cancer, past 6 months)
15. Currently have a medical diagnosis of Anorexia Nervosa or Bulimia Nervosa
16. Hospitalisation for psychiatric problems during the past 12 months
17. Planning to relocate in the next 12 months
18. Another member (excluding the enrolled child) of the household is participating in this research study

Child Exclusion Criteria

1. Currently enrolled in any weight loss related programmes
2. Diagnosed with Prader- Willi syndrome, Cushing Syndrome, Hypothyroidism or Hashimoto's Disease.
3. Weight loss of ≥ 5% in the previous 6 months.
4. Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.
5. Currently have type 1 or type II diabetes (pre-diabetes acceptable);
6. Currently have chronic/inflammatory gastrointestinal disorder (irritable bowel syndrome acceptable)
7. Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems)
8. Taking any prescription medication with known effects on appetite or weight.
9. Major surgery within the previous 12 months.
10. Presence of implanted cardiac defibrillator or pacemaker.
11. History of cancer within past 5 years or current treatment for cancer
12. Hospitalisation for psychiatric problems during the past 12 months
13. Another child of the household is participating in this research study

    -

Primary outcomes:
measure: Recruitment to online screener
timeFrame: Baseline
measure: Number of eligible participant
timeFrame: Baseline
measure: Number of non eligible participant dyads
timeFrame: Baseline
measure: Reason for non-eligibility
timeFrame: Baseline
measure: Number of participant dyads invited to baseline appointment
timeFrame: Baseline
measure: Number of baseline appointments completed
timeFrame: Baseline
measure: Number of follow up appointments completed
timeFrame: 3 month follow up
measure: Number of withdrawals
timeFrame: 3 month follow up
measure: Time point of withdrawal
timeFrame: 3 month follow up
measure: Reason for withdrawal
timeFrame: 3 month follow up
measure: Number of parent height and weights collected
timeFrame: 3 month follow up
measure: Number of child height and weights collected
timeFrame: 3 month follow up
measure: Reason for non-completion of data collection protocol
timeFrame: 3 month follow up
measure: Trial acceptability qualitatively assessed through interviews with participants
timeFrame: 3 month follow up
measure: Compliance with WW intervention
timeFrame: 3 month follow up
measure: Reasons for participation
timeFrame: 3 month follow up
measure: Testing of assumptions of parental attendance having potential to impact on child outcomes
timeFrame: 3 month follow up.
Secondary outcomes:
Other outcomes:
measure: Difference in child BMI (Weight(kg)/ Height(m)²)z score
timeFrame: Baseline and 3 month follow up
measure: Differences in weight (kg) change of adult
timeFrame: Baseline and 3 month follow up
measure: Differences in weight (kg) change of child
timeFrame: Baseline and 3 month follow up
measure: Difference in waist circumference (cm) of adult
timeFrame: Baseline and 3 month follow up
measure: Difference in waist circumference (cm) of child
timeFrame: Baseline and 3 month follow up
measure: Fitness (sit to stand test) adult
timeFrame: Baseline and follow up
measure: Fitness (sit to stand test) child
timeFrame: Baseline and follow up
measure: Flexibility (sit and reach) adult
timeFrame: Baseline and follow up
measure: Flexibility (sit and reach) child
timeFrame: Baseline and follow up
measure: Parenting self-efficacy (via Dumka PSAM).
timeFrame: Baseline and follow up
measure: Family eating behaviours (via Golan Family Eating and Activity Habits Questionnaire).
timeFrame: Baseline and 3 month follow up
measure: Self-efficacy of diet and exercise behaviours (Sallis 1988)
timeFrame: Baseline and 3 month follow up
Locations:
city: Leeds
country: United Kingdom
facility: Clinical Trials Research Unit, University of Leeds
state: West Yorkshire
Study officials:
affiliation: Clinical Trials Research Unit, University of Leeds
name: Maria Bryant, PhD
role: PRINCIPAL_INVESTIGATOR
References: