Randomized Controlled Trial of an International Commercial Program on Weight Loss and Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 7
- 主要终点
- Change in Weight from Baseline to Month 12
研究概览
简要总结
This study is a randomized controlled trial (RCT) of the Weight Watchers (WW) Freestyle ® (Flex® in UK) weight loss program compared to a control group following a do-it-yourself (DIY) approach for 12 months. Participants in the United States, Canada and the UK (n=360 total) will be randomly assigned to either participate in the commercially available WW program in their local community or to follow their own approach for weight loss. This study will examine the impact of the WW program on weight, fitness levels, quality of life, health behaviors and other health outcomes in overweight and obese adults after 3 and 12 months.
详细描述
The purpose of this study is to compare the effectiveness of the Weight Watchers program delivered in the community to a DIY approach for weight loss.
Potential participants will be recruited through a variety of advertisement methods. Those individuals responding to these advertisements will undergo web-based preliminary screening. Initially eligible individuals will be contacted by phone to receive more detailed information and to complete screening. Eligible and interested participants will be consented in person and complete screening assessments that will be used to confirm eligibility (height and weight to determine body mass index, resting blood pressure. For participants deemed to be eligible and randomized to participate in this study, these measures will also be used as their baseline data from analysis. Additional data collection will be collected at the baseline assessment visit, with assessments repeated at 3 months and after the intervention at 12 months. Assessments will include the following:
Height and Weight Resting Blood Pressure and Heart Rate Aerobic Stamina Flexibility Waist Circumference Dietary Intake Additional Questionnaires to assess demographics, sleep, food cravings, hunger and satiety, weight control strategies, affect, lifestyle activities
Group assignment will be revealed to study participants in a separate visit/contact after all assessment procedures and randomization is completed. The contact will last 15-30 minutes and participants will be provided with the resources they need to either follow the Weight Watchers program or the DIY approach. The Weight Watchers orientation and DIY intervention will not be provided by staff who collect measurements in order to preserve the blinding of the measurement staff. Following randomization reveal, the staff will maintain communication in order to promote retention (e.g., birthday card or small token reinforcer such as a water bottle sent to all participants).
WEIGHT WATCHERS FREESTYLE (FLEX) GROUP Intervention Description Participants randomized to the WW Freestyle (Flex) treatment arm will be referred to their local WW Meetings + Online Plus program delivered at a WW center / meeting convenient to them. At the randomization visit, they will be provided with a code to sign up for the Weight Watchers program free of charge for 12 months. They will also be guided to download the smartphone app on their phone, provided with a list of local meetings, and instructed on how to start the Weight Watchers intervention.
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
Outcomes assessor will be blinded to participant treatment condition.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ages 18-75 years
- •With or without previous WW experience
- •Self-reported height/weight resulting in a Body Mass Index (BMI) of 25 to 45 (will be confirmed at the Baseline Assessment visit).
- •Self report that he/she feels the need to lose weight.
- •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 be randomized to one of two groups and follow recommendations according to study protocol.
- •Willing to include demographic information (e.g., ethnicity, income and education).
- •Use of a personal smartphone (iOS 9.0 or Android 4.1)
- •The willingness and ability to download, navigate and use applications on their smartphone on a daily basis (minimum training will be provided)
- •Ability to commit to attending study assessment visits at 0, 3 and 12 months
- •Residing within 30 miles of a study assessment location
- •Read, write and speak English
排除标准
- •Participants that were a member of Weight Watchers within the past 12 months.
- •Unwilling to refrain from using Weight Watchers if assigned to the DIY group.
- •Participants that are involved in any other research studies at this time (also, cannot join other research studies while in this study, over the next 12 months) that would interfere with their ability to adhere to the protocol (i.e., attend assessment visits, attend WW meetings).
- •Given birth past six months, currently pregnant, or planning on becoming pregnant over the next 12 months.
- •Weight loss of ≥ 5 kg in the previous 6 months (and kept > 5 kg off).
- •Ever been diagnosed with an eating disorder (anorexia nervosa, bulimia).
- •Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems)
- •Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.
- •Taking any prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications such as Qsymia, Contrave, etc.) with the exception of subjects on a stable dose of Selective serotonin reuptake inhibitors (SSRIs) for 6 months
- •Currently have chronic/inflammatory gastrointestinal disorder (irritable bowel syndrome acceptable).
- •History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months.
- •Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg (confirmed at baseline visit)
- •Currently have type 1 or type 2 diabetes
- •Ever had surgical procedure for weight loss.
- •Major surgery within the previous 6 months that would interfere with consuming a regular diet and performing physical activity such as walking.
- •Presence of implanted cardiac defibrillator or pacemaker.
- •History of cancer within past 5 years or current treatment for cancer (completely resected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrollment).
- •Hospitalization for psychiatric problems during the past 12 months
- •Planning to relocate in the next 12 months
- •Another member of the household is participating in this research study
结局指标
主要结局
Change in Weight from Baseline to Month 12
时间窗: Baseline, Month 12
Weight will be measured in kg on a digital scale
次要结局
- Change in weight from Baseline to Month 3(Baseline, Month 3)
- Change in weight control strategies used from Baseline to Month 12(12 months)
- Change in Health-Promoting Lifestyle Practices Score from Baseline to Month 3(3 months)
- Change in Health-Promoting Lifestyle Practices Score from Baseline to Month 12(Baseline, Month 12)
- Percent weight change at Month 3(Month 3)
- Change in resting pulse from Baseline to Month 12(Baseline, Month 12)
- Change in Body Mass Index (BMI) from Baseline to Month 3(Baseline, Month 3)
- Change in Body Mass Index (BMI) from Baseline to Month 12(Baseline, Month 12)
- Change in Blood pressure from Baseline to Month 12(Baseline, Month 12)
- Percent weight change at Month 12(Month 12)
- Change in resting pulse from Baseline to Month 3(Baseline, Month 3)
- Change in Sleep Scores from Baseline to Month 12(Baseline, Month 12)
- Change in Quality of Life Score from Baseline to Month 3(Baseline, Month 3)
- Change in Aerobic stamina from Baseline to Month 3 (walk test)(3 months)
- Change in Blood pressure from Baseline to Month 3(Baseline, Month 3)
- Change in VAS Scores for Hunger and fullness from Baseline to Month 12(Baseline, Month 12)
- Change in Dietary intake Score from Baseline to Month 3(Baseline, Month 3)
- Change in Flexibility from Baseline to Month 3(Baseline, Month 3)
- Change in Flexibility from Baseline to Month 12(Baseline, Month 12)
- Change in Aerobic stamina from Baseline to Month 12 (walk test)(Baseline, Month 12)
- Change in Sleep Scores from Baseline to Month 3(Baseline, Month 3)
- Change in Food craving Scores from Baseline to Month 3(Baseline, Month 3)
- Change in Food craving Scores from Baseline to Month 12(Baseline, Month 12)
- Change in VAS Scores for Hunger and fullness from Baseline to Month 3(Baseline, Month 3)
- Change in weight control strategies used from Baseline to Month 3(Baseline, Month 3)
- Change in Happiness Scores from Baseline to Month 3(3 months)
- Change in Happiness Scores from Baseline to Month 12(Baseline, Month 12)
- Change in Positive and Negative affect Score from Baseline to Month 12(Baseline, Month 12)
- Change in Dietary intake Score from Baseline to Month 12(Baseline, Month 12)
- Change in Quality of Life Score from Baseline to Month 12(Baseline, Month 12)
- Change in Positive and Negative affect Score from Baseline to Month 3(3 months)
- Change in exercise capacity from Baseline to 12 months (sit to stand test)(Baseline, Month 12)
- Change in exercise capacity from baseline to 3 months (sit to stand test)(Baseline, Month 3)