University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
NCT Number: NCT03079128
There is a body of evidence that has evaluated the effect of Weight Watchers, a commercially available weight loss program, on changes in body weight. The current investigation aims to add to this body of evidence by providing additional data on changes in body weight and enhance the current evidence-base in regards to evaluating other health-related outcomes.
There is little evidence that demonstrates whether or not the weight loss as a result of the Weight Watchers program elicits changes in health-related functional outcomes such as aerobic capacity, flexibility, sleep, and other psychological measures. Additionally, within a scientific research protocol, measures of adherence and satisfaction will also be evaluated evaluated. This study will evaluate these outcomes beyond weight changes achieved across the 24-week program.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15261, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Weight Watchers Intervention
Time frame: Baseline, 3 months, and 6 months
To examine the effect of a 24-week commercially available weight loss program on weight change.
Time frame: Baseline, 3 months, and 6 months
Aerobic Capacity: Participants will complete a 6 minute walk test on a designated walking course. The 6 minute walk test is a measure of functional and aerobic capacity. Participants will asked to walk at a brisk, yet comfortable pace for a total of 6 minutes.
Time frame: Baseline, 3 months, and 6 months
Flexibility: Lower body flexibility will be assessed through the sit and reach test. The sit and reach is a common test to measure lower back and lower body flexibility.
Time frame: Baseline, 3 months, and 6 months
Sleep quality and duration. Participants will be asked to complete the Pittsburgh Sleep Quality Index (PSQI) at baseline, Months 3 and 6. The PSQI is a validated self-report measure of sleep duration and sleep quality.
Time frame: Baseline, 3 months, and 6 months
Participants will be asked to complete the Oxford Happiness Questionnaire at baseline, Months 3 and 6. The OHQ is a validated self-report measure for broad personal happiness. Respondents rate 29 sentences on a 6 point Likert scale (1, strongly disagree; 6, strong agree).
Time frame: Baseline, 3 months, and 6 months
The Food Craving Inventory-II (FCI-II) is a validated self-report measure for general cravings and cravings for specific types of foods and will be completed at baseline, Months 3 and 6. Respondents rate the frequency of cravings since the last time they completed the survey for each of 33 food items using a five-point Likert scale (1, never; 2, rarely; 3, sometimes; 4, often; 5, always/almost every day). The FCI-II consists of 5 scales (sweets, high fats, carbohydrates/starches, fast food fats, and fruits & vegetables) that constitute the higher order construct of food cravings (the total score).
Time frame: Baseline, 3 months, and 6 months
Data on adherence (attendance at meetings and use of the points system) will also be collected. Attendance data will be recorded by Weight Watchers staff at every meeting. These data will be confirmed by a member of the research staff that will be attending the weekly Weight Watchers meetings. In addition, the weekly weights obtained at the intervention sessions will be provided to the investigators by the intervention staff to allow for examination of the trajectory of weight loss.
Time frame: 3 months and 6 months
Program Satisfaction:
Participants will be asked to complete a program Satisfaction Survey. The Satisfaction Survey is a self-administered survey scored on a 5-point Likert scale.
Time frame: 6 months
Program Satisfaction:
Open-ended Satisfaction Survey. Participants will be asked to complete a Open-ended Satisfaction survey that consist of 2 open-ended questions, and asked respondents to report on their satisfaction with the program.
Time frame: Baseline, 3 months, and 6 months
The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is a validated self-report measure for an individual's perception of how their weight affects their day-to-day life and will be completed at baseline, Months 3 and 6. Respondents rate the degree to which their weight affects them on 31 items using a five-point Likert scale (1, never true; 2, rarely true; 3, sometimes true; 4, usually true; 5, always true). The IWQOL-Lite consists of 5 scales (physical function, self-esteem, sexual life, public distress, and work).
Time frame: Baseline, 3 months, and 6 months
The most commonly used tool to measure subjective sensations of hunger is the Visual Analogue Scale (VAS). A VAS measures sensations that range across a continuum of values and cannot be easily directly measured. Operationally, the VAS is a horizontal line measuring exactly 100 mm in length, anchored by word descriptors (i.e., Not at all hungry, Extremely hungry) at each end. At baseline, Months 3 and 6, participants will be asked to complete a three item VAS by placing a mark on the line at the point they feel represents their response to the question.
University of Pittsburgh
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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