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

Obesity, Childhood Clinical Trial

— WWChild  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04242641
• Other study ID #: MREC 19-0.23
• Status: Terminated
• Phase: N/A
• Start date: January 24, 2020
• Est. completion date: April 1, 2020

Study information

• Verified date: August 2021
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 75 Years

Eligibility

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

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Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• WW
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.

Locations

Country	Name	City	State
United Kingdom	Clinical Trials Research Unit, University of Leeds	Leeds	West Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	WW International Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in child BMI (Weight(kg)/ Height(m)²)z score	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
Other	Differences in weight (kg) change of adult	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
Other	Differences in weight (kg) change of child	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
Other	Difference in waist circumference (cm) of adult	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
Other	Difference in waist circumference (cm) of child	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
Other	Fitness (sit to stand test) adult	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
Other	Fitness (sit to stand test) child	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
Other	Flexibility (sit and reach) adult	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
Other	Flexibility (sit and reach) child	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
Other	Parenting self-efficacy (via Dumka PSAM).	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
Other	Family eating behaviours (via Golan Family Eating and Activity Habits Questionnaire).	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
Other	Self-efficacy of diet and exercise behaviours (Sallis 1988)	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
Primary	Recruitment to online screener	Number of individuals that self-refer to the WWChild online screener	Baseline
Primary	Number of eligible participant	The number of eligible parent-child dyads that complete both the online and telephone screening process that determines eligibility.	Baseline
Primary	Number of non eligible participant dyads	The number of dyads that complete both the online and telephone screener who are not eligible	Baseline
Primary	Reason for non-eligibility	The number of participants who are ineligible for each reason for not being included in the study	Baseline
Primary	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
Primary	Number of baseline appointments completed	The total number of participant dyads that complete baseline appointments	Baseline
Primary	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
Primary	Number of withdrawals	The total number of withdrawals from the study	3 month follow up
Primary	Time point of withdrawal	The time point within the study of withdrawals	3 month follow up
Primary	Reason for withdrawal	The number of participants that withdraw for each reason	3 month follow up
Primary	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
Primary	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
Primary	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
Primary	Trial acceptability qualitatively assessed through interviews with participants	Qualitative interviews with parents will assess the acceptability of the study.	3 month follow up
Primary	Compliance with WW intervention	Intervention attendance and usage of the intervention app will be analysed to measure compliance of intervention	3 month follow up
Primary	Reasons for participation	Qualitative interviews will be used to explore reasons for participation in the study and potential barriers.	3 month follow up
Primary	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.