The study is a randomized clinical trial with the primary aim of determining the effectiveness of the WW intervention at reducing HbA1c in patients with type 2 diabetes.
This study is a 12-month, two-arm, parallel controlled trial. Up to 486 adults with overweight or obesity and type 2 diabetes will be randomized to either 1) intervention or 2) usual care. The intervention arm will participate in a WW program which will include access to weekly Virtual Workshops and the WW App. WW is a widely available, commercial behavioral weight management program that encourages healthy habits in the areas of food, activity, mindset, and sleep, with topics specific to diabetes. Participants in the usual care arm will receive their normal, usual care from their healthcare providers in addition to a session with a Registered Dietician at baseline. All patients will participate in the collection of patient-reported outcomes at baseline and at 6 and 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
The core of the WW food program is the SmartPoints® system. Briefly, the SmartPoints® system assigns each food and beverage a SmartPoints® value per volume based on four components: calories, sugar, saturated fat, and protein. Certain foods have a SmartPoints® value of zero (ZeroPoint foods). These foods (e.g., lean sources of protein such as skinless chicken breast and vegetables) form the basis of a healthy eating pattern, are at low risk for overconsumption and do not have to be weighed, measured or tracked. Participants were assigned a personalized SmartPoints® Budget, based on reported food and lifestyle preferences, and designed to create an energy deficit, using the Mifflin St-Jeor formula, which uses age, sex, height, and weight to estimate resting energy expenditure.
The Usual Care group will continue to receive routine medical care by their provider, in addition to receiving one 50-minute virtual on-line session of nutrition counseling with a registered dietitian, with additional materials at the time of their 6- and 12-month follow-up assessments.
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Wake Forest University Health Sciences
Greensboro, North Carolina, United States
University of Pittsburgh Health Sciences
Pittsburgh, Pennsylvania, United States
Change in HbA1c% at 6 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Time frame: Baseline and 6 months.
Change in HbA1c% at 12 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Time frame: Baseline and 12 months.
Percent weight loss at 6 months
Body weight is measured using standard methods with the patient wearing light clothing
Time frame: Baseline and 6 months
Percent weight loss at 12 months
Body weight is measured using standard methods with the patient wearing light clothing
Time frame: Baseline and 12 months
Change in waist circumference at 6 months
Waist circumference is measured using standard methods with an inelastic tape
Time frame: Baseline and 6 months
Change in waist circumference at 12 months
Waist circumference is measured using standard methods with an inelastic tape
Time frame: Baseline and 12 months
Change in systolic blood pressure at 6 months
Systolic blood pressure is measured using standard clinical methods
Time frame: Baseline and 6 months
Change in systolic blood pressure at 12 months
Systolic blood pressure is measured using standard clinical methods
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Time frame: Baseline and 12 months
Change in diastolic blood pressure at 6 months
Diastolic blood pressure is measured using standard clinical methods
Time frame: Baseline and 6 months
Change in diastolic blood pressure at 12 months
Diastolic blood pressure is measured using standard clinical methods
Time frame: Baseline and 12 months
Change in total cholesterol at 6 months
Total cholesterol is assayed using standard laboratory methods
Time frame: Baseline and 6 months
Change in total cholesterol at 12 months
Total cholesterol is assayed using standard laboratory methods
Time frame: Baseline and 12 months
Change in high-density lipoprotein cholesterol at 6 months
High-density lipoprotein cholesterol is assayed using standard laboratory methods
Time frame: Baseline and 6 months
Change in high-density lipoprotein cholesterol at 12 months
High-density lipoprotein cholesterol is assayed using standard laboratory methods
Time frame: Baseline and 12 months
Change in low-density lipoprotein cholesterol at 6 months
Low-density lipoprotein cholesterol is estimated using standard laboratory methods
Time frame: Baseline and 6 months
Change in low-density lipoprotein cholesterol at 12 months
Low-density lipoprotein cholesterol is estimated using standard laboratory methods
Time frame: Baseline and 12 months
Change in triglycerides at 6 months
Triglycerides are assayed using standard laboratory methods
Time frame: Baseline and 6 months
Change in triglycerides at 12 months
Triglycerides are assayed using standard laboratory methods
Time frame: Baseline and 12 months
Change in physical activity at 6 months
Physical activity is assessed with the Global Physical Activity Questionnaire. A valid and reliable instrument from the World Health Organization that measures physical activity intensity, duration, and frequency in three domains: occupational physical activity, transport-related physical activity, and physical activity during discretionary or leisure time. It also captures sedentary time. There are 16 questions.
Time frame: Baseline and 6 months
Change in physical activity at 12 months
Physical activity is assessed with the Global Physical Activity Questionnaire. A valid and reliable instrument from the World Health Organization that measures physical activity intensity, duration, and frequency in three domains: occupational physical activity, transport-related physical activity, and physical activity during discretionary or leisure time. It also captures sedentary time. There are 16 questions.
Time frame: Baseline and 12 months
Change in dietary intake at 6 months
Dietary Intake will be assessed using DietID (www.DietID.com). DietID harnesses diet quality photo navigation technology to identify participant's dietary intake by showing a series of images that participants select based on what reflects their current dietary pattern. Once a pattern is identified, DietID provides nutrient intake data and a Healthy Eating Index 2015 score.
Time frame: Baseline and 6 months
Change in dietary intake at 12 months
Dietary Intake will be assessed using DietID (www.DietID.com). DietID harnesses diet quality photo navigation technology to identify participant's dietary intake by showing a series of images that participants select based on what reflects their current dietary pattern. Once a pattern is identified, DietID provides nutrient intake data and a Healthy Eating Index 2015 score.
Time frame: Baseline and 12 months
Change in perceived stress at 6 months
Perceived stress is measured using the Perceived Stress Scale, a 10-item questionnaire that measures the extent to which a participant's life is unpredictable, uncontrollable, and overloading. It was designed for use in older adolescents and adults, and is considered to have adequate internal reliability and construct validity. Each question asks about how the participant has felt or thought in the past month and uses a 5-point Likert scale (0=never, 4=very often). Scores are calculated by summing responses and higher scores indicate greater perceived stress.
Time frame: Baseline and 6 months
Change in perceived stress at 12 months
Perceived stress is measured using the Perceived Stress Scale, a 10-item questionnaire that measures the extent to which a participant's life is unpredictable, uncontrollable, and overloading. It was designed for use in older adolescents and adults, and is considered to have adequate internal reliability and construct validity. Each question asks about how the participant has felt or thought in the past month and uses a 5-point Likert scale (0=never, 4=very often). Scores are calculated by summing responses and higher scores indicate greater perceived stress.
Time frame: Baseline and 12 months
Change in diabetes distress at 6 months
The Diabetes Distress Scale contains 17 total items with 4 subscales: Emotional Burden (items 1, 3, 8, 11, 14), Physician-related distress (items 2, 4, 9, 15), Regimen-related distress (items 5, 6, 10, 12, 16), and Interpersonal distress (7, 13, 17). The total score is calculated by taking an average of participant responses to all 17 items. In the same manner, each subscale can have its own score by taking an average of subscale specific participant responses. A mean item score of 3 or higher is considered moderate distress and a level of distress worthy of clinical attention. The Diabetes Distress scale has been tested for reliability and validity in US based populations and abroad.
Time frame: Baseline and 6 months
Change in diabetes distress at 12 months
The Diabetes Distress Scale contains 17 total items with 4 subscales: Emotional Burden (items 1, 3, 8, 11, 14), Physician-related distress (items 2, 4, 9, 15), Regimen-related distress (items 5, 6, 10, 12, 16), and Interpersonal distress (7, 13, 17). The total score is calculated by taking an average of participant responses to all 17 items. In the same manner, each subscale can have its own score by taking an average of subscale specific participant responses. A mean item score of 3 or higher is considered moderate distress and a level of distress worthy of clinical attention. The Diabetes Distress scale has been tested for reliability and validity in US based populations and abroad.
Time frame: Baseline and 12 months
Change in quality of life at 6 months
The Impact of Weight on Quality of Life-Lite is a validated self-report measure for an individual's perception of how their weight affects their day-to-day life. 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 and 6 months
Change in quality of life at 12 months
The Impact of Weight on Quality of Life-Lite is a validated self-report measure for an individual's perception of how their weight affects their day-to-day life. 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 and 12 months
Change in well-being at 6 months
Well-being will be measured using the World Health Organization-5 Well-being Index, which consists of five statements, which respondents rate, in relation to the past two weeks, using a six-point Likert scale (0, at no time; 1, some of the time; 2, less than half of the time; 3, more than half of the time; 4, most of the time; 5, all of the time). The total raw score ranges from 0 to 25, and is multiplied by 4 to give the final score, with 0 representing the worse imaginable well-being and 100 representing the best imaginable well-being.
Time frame: Baseline and 6 months
Change in well-being at 12 months
Well-being will be measured using the World Health Organization-5 Well-being Index, which consists of five statements, which respondents rate, in relation to the past two weeks, using a six-point Likert scale (0, at no time; 1, some of the time; 2, less than half of the time; 3, more than half of the time; 4, most of the time; 5, all of the time). The total raw score ranges from 0 to 25, and is multiplied by 4 to give the final score, with 0 representing the worse imaginable well-being and 100 representing the best imaginable well-being.
Time frame: Baseline and 12 months
Change in habit strength at 6 months
Habit strength will be assessed with the Self-Report Behavioral Automaticity Index, a 4-item measure that that is reliable, correlates highly with existing measures, and is sensitive to effects that characterize habits. The 4-items assess whether Behavior X is something... "I do automatically", "I do without having to consciously remember", "I do without thinking", and "I start doing before I realize I'm doing it". Items are scored using a 7-point Likert scale ranging from strongly disagree to strongly agree.
Time frame: Baseline and 6 months
Change in habit strength at 12 months
Habit strength will be assessed with the Self-Report Behavioral Automaticity Index, a 4-item measure that that is reliable, correlates highly with existing measures, and is sensitive to effects that characterize habits. The 4-items assess whether Behavior X is something... "I do automatically", "I do without having to consciously remember", "I do without thinking", and "I start doing before I realize I'm doing it". Items are scored using a 7-point Likert scale ranging from strongly disagree to strongly agree.
Time frame: Baseline and 12 months
Change in emotional eating at 6 months
Emotional eating will be measured with the Palatable Eating Motives Scale- Coping Subscale, which measures intentionally using palatable food to cope with negative feelings and has demonstrated reliability, convergent validity and discriminant validity. The coping subscale additionally demonstrated incremental validity with BMI. The coping subscale consists of 4 questions with response options Almost Never/Never to Almost always/Always.
Time frame: Baseline and 6 months
Change in emotional eating at 12 months
Emotional eating will be measured with the Palatable Eating Motives Scale- Coping Subscale, which measures intentionally using palatable food to cope with negative feelings and has demonstrated reliability, convergent validity and discriminant validity. The coping subscale additionally demonstrated incremental validity with BMI. The coping subscale consists of 4 questions with response options Almost Never/Never to Almost always/Always.
Time frame: Baseline and 12 months
Change in hunger at 6 months
Hunger will be measured using the Hunger Visual Analogue Scale, which is a reliable measure for appetite research. The Hunger Visual Analogue Scale asks "How hungry did you feel over the past week" and is composed of a line with words anchored at each end describing the extremes (Not at all hungry, Extremely hungry). Participants are asked to make a mark on the line corresponding to their feelings and quantification of the measurement is done by measuring the distance from the left end of the mark.
Time frame: Baseline and 6 months
Change in hunger at 12 months
Hunger will be measured using the Hunger Visual Analogue Scale, which is a reliable measure for appetite research. The Hunger Visual Analogue Scale asks "How hungry did you feel over the past week" and is composed of a line with words anchored at each end describing the extremes (Not at all hungry, Extremely hungry). Participants are asked to make a mark on the line corresponding to their feelings and quantification of the measurement is done by measuring the distance from the left end of the mark.
Time frame: Baseline and 12 months
Change in diabetes medications at 6 months
The number of diabetes medications is summed at each time point
Time frame: Baseline and 6 months
Change in diabetes medications at 12 months
The number of diabetes medications is summed at each time point
Time frame: Baseline and 12 months
Change in proportion of patents achieving an HbA1c% <=6.5% at 6 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Time frame: Baseline and 6 months
Change in proportion of patents achieving an HbA1c% <=6.5% at 12 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Time frame: Baseline and 12 months
Change in proportion of patents achieving an HbA1c% <=7% at 6 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Time frame: Baseline and 6 months
Change in proportion of patents achieving an HbA1c% <=7% at 12 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Time frame: Baseline and 12 months
Change in food cravings at 6 months
Food cravings will be assessed using the Food Cravings Inventory, a 33-item self-report measure designed to assess the subjective experience of food craving across 33 different foods. The measure consists of 5 empirically-derived factors: high fats, sweets, carbohydrates, starches, fast food fats, \& fruits and vegetables. The questionnaire is scaled in a frequency format, assessing the frequency with which an individual experiences a craving for a particular food. All items are scored in the following manner: Never = 1, Rarely = 2, Sometimes = 3, Often = 4, \& Always=5. Fat = Average of items 3,4,7,11,17,23,31,32. Sweet=Average of items 1,9,15,19,20,27,28,30. Carb=Average of items 6,10,14,16,22,25,26,33. FFF=Average of items 2,8,13,24. FCI-Fr/Veg=Average of items 5,12,18,21,29. Total=Average of all 33 items.
Time frame: Baseline and 6 months
Change in food cravings at 12 months
Food cravings will be assessed using the Food Cravings Inventory, a 33-item self-report measure designed to assess the subjective experience of food craving across 33 different foods. The measure consists of 5 empirically-derived factors: high fats, sweets, carbohydrates, starches, fast food fats, \& fruits and vegetables. The questionnaire is scaled in a frequency format, assessing the frequency with which an individual experiences a craving for a particular food. All items are scored in the following manner: Never = 1, Rarely = 2, Sometimes = 3, Often = 4, \& Always=5. Fat = Average of items 3,4,7,11,17,23,31,32. Sweet=Average of items 1,9,15,19,20,27,28,30. Carb=Average of items 6,10,14,16,22,25,26,33. FFF=Average of items 2,8,13,24. FCI-Fr/Veg=Average of items 5,12,18,21,29. Total=Average of all 33 items.
Time frame: Baseline and 12 months
Change in self compassion at 6 months
Self-compassion will be assessed using the Self-Compassion Scale, a 26-item measure of self-compassion that is psychometrically valid and theoretically coherent. The scale consists of six subscales: self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identified. Subscales are computed by calculating the mean of subscale item responses. A total self-compassion score can be obtained by reverse scoring the negative subscale items (self-judgement, isolation, and over-identification) and computing a grand mean of all six subscale means.
Time frame: Baseline and 6 months
Change in self compassion at 12 months
Self-compassion will be assessed using the Self-Compassion Scale, a 26-item measure of self-compassion that is psychometrically valid and theoretically coherent. The scale consists of six subscales: self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identified. Subscales are computed by calculating the mean of subscale item responses. A total self-compassion score can be obtained by reverse scoring the negative subscale items (self-judgement, isolation, and over-identification) and computing a grand mean of all six subscale means.
Time frame: Baseline and 12 months
Change in restraint/disinhibition at 6 months
The Three Factor Eating Questionnaire- Restraint and Disinhibition subscales measures cognitive restraint of eating and disinhibition. The scales contain 37 items and have been tested for reliability and validity. Higher scores indicate greater levels of restraint or disinhibition.
Time frame: Baseline and 6 months
Change in restraint/disinhibition at 12 months
The Three Factor Eating Questionnaire- Restraint and Disinhibition subscales measures cognitive restraint of eating and disinhibition. The scales contain 37 items and have been tested for reliability and validity. Higher scores indicate greater levels of restraint or disinhibition.
Time frame: Baseline and 12 months
Change in body appreciation at 6 months
The Body Appreciation Scale measures individuals acceptance of, favorable opinions toward, and respect for their bodies. The scale demonstrates internal consistency, convergent validity, incremental validity, and discriminant validity. Measurement invariance upheld across sexes and US sample types (college vs. community samples). There are 10 items, each assessed on a scale from 1-never to 5-always.
Time frame: Baseline and 6 months
Change in body appreciation at 12 months
The Body Appreciation Scale measures individuals acceptance of, favorable opinions toward, and respect for their bodies. The scale demonstrates internal consistency, convergent validity, incremental validity, and discriminant validity. Measurement invariance upheld across sexes and US sample types (college vs. community samples). There are 10 items, each assessed on a scale from 1-never to 5-always.
Time frame: Baseline and 12 months
Change in weight bias at 6 months
The Weight Bias Internalization Scale has 13 items and responses are rated on a 7-point Likert scale (strongly disagree -strongly agree). Responses provide insight on the participant's internalized beliefs and feelings regarding their weight. There are two subscales: Weight-Related Distress (7 items; 7-13; Cronbach's alpha =0.910) and Weight-Related Self-Devaluation (6 items; 1-6; Cronbach's alpha =0.763). The scale has been tested for validity in people with overweight and obesity and the two factor model demonstrated good to excellent fit with the data. Scores are calculated by taking an average of the response values. Questions 1,2,4,5, should be reverse scored before calculating the average.
Time frame: Baseline and 6 months
Change in weight bias at 12 months
The Weight Bias Internalization Scale has 13 items and responses are rated on a 7-point Likert scale (strongly disagree -strongly agree). Responses provide insight on the participant's internalized beliefs and feelings regarding their weight. There are two subscales: Weight-Related Distress (7 items; 7-13; Cronbach's alpha =0.910) and Weight-Related Self-Devaluation (6 items; 1-6; Cronbach's alpha =0.763). The scale has been tested for validity in people with overweight and obesity and the two factor model demonstrated good to excellent fit with the data. Scores are calculated by taking an average of the response values. Questions 1,2,4,5, should be reverse scored before calculating the average.
Time frame: Baseline and 12 months