Cleveland Clinic
Cleveland, Ohio, 44195, United States
NCT Number: NCT06034457
The study objective is to evaluate the efficacy of the WeightWatchers (WW) GLP-1 behavioral program + WW Clinic (formerly known as Sequence medical weight management program) on weight loss and related outcomes. Participants will be invited to take part and answer surveys at 0, 12 and 24 weeks.
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Notify Me18 year and older
All sexes
Observational
Cleveland, Ohio, 44195, United States
This is a 24 week prospective single-arm efficacy outcomes study. Up to 180 adult participants who are currently enrolled in WW GLP-1 behavioral program program + WW Clinic (formerly known as Sequence medical weight management program) and already prescribed semaglutide or tirzepatide. The application of a comprehensive lifestyle-based intervention focused on dietary intake, physical activity, support and behavioral principles in conjunction with anti-obesity medication (AOM) is novel and may increase AOM efficacy while minimizing maintenance concerns. As obesity care can now be delivered virtually, it will also include an innovative strategy of virtual/remotely delivered medical care via Sequence and WW. Further, this study will examine multiple psychosocial domains associated with weight loss and weight loss related outcomes including physical activity, dietary behavior, disordered eating, depression symptoms, internalized weight bias and community, that have not been examined in AOM trials.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 0 to 24 weeks
Effect of WW GLP1 behavioral program + WW Clinic (formerly known as Sequence) on absolute change of weight loss at 24 weeks.
Time frame: 0 to 24 weeks
Effect of WW + WW Clinic (formerly known as Sequence) on weight loss and % reaching 5, 10, 15, 20 % body weight loss at 24 weeks.
Time frame: 0 to 24 weeks
Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of blood pressure at 24 weeks
Time frame: 0 to 24 weeks
Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Quality of Life (QOL) scores using "Impact of Weight on Quality of Life-Lite Scale" Scale Name + Description of scale: "Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Is a validated, 31-item, self-report measure of obesity-specific quality of life in adults. There are five domains include physical function, self-esteem, sexual life, public distress and work.
Scale Ranges (min, max): 0-100 Description of scoring: Higher scores represent lower quality of life (i.e., greater impact of obesity on quality of life). Lower scores represent a better quality of life (i.e., less impact of obesity). A negative mean change indicates improvement in quality of life.
Time frame: 0 to 24 weeks
Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Well-being at 24 weeks using "WHO Well-Being Index 5" Scale Name + Description of scale: "Well-being Index 5 (WHO-5)" is a 5-item questionnaire that assesses subjective well-being through five statements about feeling cheerful, calm, active, interested and rested over the past two weeks.
Scale Ranges (min, max) 0-25 Description of scoring: Lower scores indicate worse overall well-being, higher scores indicate better overall well-being. A positive mean change indicates improvement in well-being.
Time frame: 0 to 24 weeks
Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Disordered Eating at 24 weeks using "Eating Disorder Examination-Questionnaire" Scale Name + Description of scale: "Eating Disorder Examination-Questionnaire (EDE-Q)" is a 28-item self-report questionnaire, adapted from the semi-structured interview, the Eating Disorder Examination (EDE). The questionnaire is designed to assess the range, frequency and severity of behaviors associated with a diagnosis of an eating disorder.
Scale Ranges (min, max): 0-6 Description of scoring: Lower scores indicate less problematic eating disordered behaviors and cognitions and higher scores indicate more problematic eating disordered behaviors and cognitions. A positive mean change indicates an increase in eating disordered symptoms. A negative mean change could indicate a decrease in eating disorder symptoms.
Time frame: 0 to 24 weeks
Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Strength Training Behavior at 24 weeks using the "Strength Training Behavior Scale" Scale Name + Description of scale: "Stage of Change for Strength Training" Strength training is defined as all activities that serve to enhance muscle strength and endurance (free weights, body weight exercises, etc.) Regular resistance training is described as engaging in these activities at least two times per week.
Scale Ranges (min, max): 0-7 Description of scoring: Lower scores indicate less days strength training. Higher scores equal more days of strength training. A positive mean change indicates an increase in number of days of strength training.
Time frame: 0 to 24 weeks
Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Stress at 24 weeks using the "Perceived Stress Scale" Scale Name + Description of scale: "Perceived Stress Scale, PSS-10" is a self-report scale that asks about feelings and thoughts related to stressful things during the last month.
Scale Ranges (min, max): 10-50 Description of scoring: Higher scores indicate more perceived stress and lower scores indicate less perceived stress. A negative mean change indicates improvement in perceived stress.
Time frame: 0 to 24 weeks
Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Emotional Eating scores using the "Palatable Eating Motives Scale-Coping Subscale" Scale Name + Description of scale: "Palatable Eating Motives Scale - Coping Subscale (PEMs-Coping)" is a four-item coping subscale of the PEMs self-report that measures eating behavior as a method of coping with problems and negative feelings.
Scale Ranges (min, max): 4-20 Description of scoring: Lower scores indicate lower frequency of eating as a method of coping with problems and negative feelings. Higher scores indicate higher frequency of eating as a method of coping with problems and negative feelings. A negative mean score indicates a decrease in using eating to cope with problems and negative feelings.
Time frame: 0 to 24 weeks
Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Unhealthy Habits scores using "Self-Reported Behavioral Automaticity Index" Scale Name + Description of scale: "Self-Reported Behavioral Automaticity Index (SRBAI)-Unhealthy Habits Subscale" is a self-report measure to assess how automatic or habitual certain behaviors are, often used to understand unhealthy habits. Unhealthy habits included are eating sugary foods, fried foods and drinking sugary drinks.
Scale Ranges (min, max): 1-7 Description of scoring: Lower scores indicate less automatic or habitual unhealthy habits. Higher scores indicate more automatic or habitual unhealthy habits. A negative mean change indicates a decrease in automatic or habitual unhealthy behaviors.
Time frame: 0 to 24 weeks
Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Habit Strength scores using the "Self-Reported Behavioral Automaticity Index for Healthy Habits" Scale Name + Description of scale: "Self-Reported Behavioral Automaticity Index (SRBAI) Healthy Habits Subscale" is a self-report measure to assess how automatic or habitual certain behaviors are, often used to understand healthy habits. Healthy habits included are portion control, food tracking, protein content, eating vegetables, weighing self, physical activity, positive self-talk after a setback, arranging kitchen so healthy foods are easy to access and meal planning.
Scale Ranges (min, max): 1-7 Description of scoring: Lower scores indicate less automatic or habitual healthy habits. Higher scores indicate more automatic or habitual healthy habits. A positive mean change indicates an increase in automatic or habitual healthy behaviors.
Time frame: 0 to 24 weeks
Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Weight Bias Internalization scores using "Weight Bias Internalization Scale" Scale Name + Description of scale: "Weight Bias Internalization Scale, WBIS-2F" is a 13-item measure developed to assess weight related self-stigma.
Scale Ranges (min, max): 13-91 Description of scoring: Lower scores indicate more weight related self-stigma, higher scores indicate less weight related self-stigma. A negative mean change indicates a decrease in weight related self-stigma.
Time frame: 0 to 24 weeks
Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Self-Compassion scores using the "Self-Compassion Scale" Scale Name + Description of scale: "Self-Compassion Scale" is a self-report questionnaire that asks how someone typically acts towards themselves in difficult times.
Scale Ranges (min, max): 1-5 Description of scoring: Lower scores indicate that an individual might be more critical of themselves during difficult times. Higher scores might indicate someone who might be less critical on themselves during difficult times. A positive mean change indicates more self-compassion.
Time frame: 0 to 24 weeks
Number of Participants with GLP1 Side Effects from week 0 to week 24
Time frame: 0 to 24 weeks
Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Restraint/Disinhibition scores using the "Three Factor Eating Questionnaire" Scale Name + Description of scale: "Three Factor Eating Questionnaires, TFEQ". Is a self-report scale that measures three dimensions of eating behavior: cognitive restraint, disinhibition and hunger. The first two factors were included.
Scale Ranges (min, max): restraint 0-21, disinhibition 0-16 Description of scoring: Lower scores indicate less restraint. Higher scores indicate more restraint. A positive change indicates improvement in restraint. Lower scores indicate less disinhibition. Higher scores indicate more disinhibition. A negative mean change improvement in disinhibition.
Time frame: 0 to 24 weeks
Effect of WW + WW Clinic (formerly known as Sequence) on absolute change of Depression symptoms using the "Patient Health Questionnaire-8"
Scale Name + Description of scale: "Patient Health Questionniare-8 item" is a self-report scale that rates depressive symptoms including questions about interest, enjoyment, sadness, sleep, appetite, energy, guilt, concentration.
Scale Ranges (min, max): 0-24
Description of scoring: Lower scores indicate fewer depressive symptoms, higher scores indicate more depressive symptoms. A negative mean change indicates an improvement in depressive symptoms.
The Cleveland Clinic
Other
24 Week External Single-arm Study Testing the Effectiveness of WW GLP1 Behavioral Program + Sequence Medical Weight Management on Weight Loss and Related Outcomes
Acronym: WW Clinic
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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