An Exploratory Study to Determine the Potential Impact of Parental Attendance at WW on Weight and Behavioural Outcomes in Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Recruitment to online screener
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to the which arm the participants have been allocated.
入排标准
- 年龄范围
- 5 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Recruitment to online screener
时间窗: Baseline
Number of individuals that self-refer to the WWChild online screener
Number of withdrawals
时间窗: 3 month follow up
The total number of withdrawals from the study
Number of parent height and weights collected
时间窗: 3 month follow up
The total number of parent participants that have had both their height and weight measured.
Number of eligible participant
时间窗: 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
时间窗: Baseline
The number of dyads that complete both the online and telephone screener who are not eligible
Number of participant dyads invited to baseline appointment
时间窗: Baseline
The total number of participant dyads that are invited to attend a baseline appointment following online and telephone eligibility screening
Reason for non-eligibility
时间窗: Baseline
The number of participants who are ineligible for each reason for not being included in the study
Time point of withdrawal
时间窗: 3 month follow up
The time point within the study of withdrawals
Reason for withdrawal
时间窗: 3 month follow up
The number of participants that withdraw for each reason
Compliance with WW intervention
时间窗: 3 month follow up
Intervention attendance and usage of the intervention app will be analysed to measure compliance of intervention
Reasons for participation
时间窗: 3 month follow up
Qualitative interviews will be used to explore reasons for participation in the study and potential barriers.
Number of follow up appointments completed
时间窗: 3 month follow up
The total number of participant dyads that complete a 3 month follow up data collection appointment
Number of child height and weights collected
时间窗: 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
时间窗: 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
时间窗: 3 month follow up
Qualitative interviews with parents will assess the acceptability of the study.
Number of baseline appointments completed
时间窗: Baseline
The total number of participant dyads that complete baseline appointments
Testing of assumptions of parental attendance having potential to impact on child outcomes
时间窗: 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.
次要结局
未报告次要终点
研究者
Maria Bryant
Associate Professor
University of Leeds