Study of an International Commercial Program on Weight Loss and Health Outcomes

Weight will be measured in kg on a digital scale

BMI in kg/m²

BMI in kg/m²

Percent of baseline weight lost or gained

Percent of baseline weight lost or gained

Systolic and diastolic blood pressure will be measured in mmHg after a 5 minute rest

Systolic and diastolic blood pressure will be measured in mmHg after a 5 minute rest

Pulse will be measured in beats per minute after a 5 minute rest

Pulse will be measured in beats per minute after a 5 minute rest

Pittsburgh Sleep Quality Index (PSQI): Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality.

Pittsburgh Sleep Quality Index (PSQI): Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality.

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 12. 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).

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 12. 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).

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., 0=Not at all hungry, 100=Extremely hungry) at each end. At baseline, Months 3 and 12, 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.

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., )0=Not at all hungry, 100=Extremely hungry) at each end. At baseline, Months 3 and 12, 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.

The Weight Control Strategies Scale (WCSS) is a 30 item self-report measure of behavioral strategies commonly used for weight loss and will be used to measure strategies used for the purpose of weight loss. The measure was validated in a pooled sample from three behavioral weight loss trials. Principal components analysis with varimax rotation revealed a four-component solution for the WCSS, representing the following subscales: Dietary Choices, Self-monitoring Strategies, Physical Activity, and Psychological Coping (α from 0.79 to 0.89). Longitudinal analyses showed that WCSS subscale scores increased during treatment (P < 0.01). In adjusted models, changes in WCSS total and subscale scores were associated with post-treatment weight loss (P < 0.01). Higher scores indicate more strategies endorsed and subscales indicate the type of strategies. Higher scores are predictive of weight loss.

The Weight Control Strategies Scale (WCSS) is a 30 item self-report measure of behavioral strategies commonly used for weight loss and will be used to measure strategies used for the purpose of weight loss. The measure was validated in a pooled sample from three behavioral weight loss trials. Principal components analysis with varimax rotation revealed a four-component solution for the WCSS, representing the following subscales: Dietary Choices, Self-monitoring Strategies, Physical Activity, and Psychological Coping (α from 0.79 to 0.89). Longitudinal analyses showed that WCSS subscale scores increased during treatment (P < 0.01). Higher scores indicate more strategies endorsed and subscales indicate the type of strategies. Higher scores are predictive of weight loss.

Diet intake will be measured using the Yale 24hr Food Frequency Questionnaire (FFQ), which is a brief nutrition self-monitoring tool measuring the intakes of fruits and vegetables, percentage energy from fat, and fiber, by focusing on specific foods consistently linked to weight gain or loss. Participants are asked to recall food consumption of various categories over 24-hour periods. The survey is currently being validated.

Participants will be asked to complete the Oxford Happiness Questionnaire (OHQ)at baseline, Months 3 and 12. 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).

Diet intake will be measured using the Yale 24hr FFQ, which is a brief nutrition self-monitoring tool measuring the intakes of fruits and vegetables, percentage energy from fat, and fiber, by focusing on specific foods consistently linked to weight gain or loss. Participants are asked to recall food consumption of various categories over 24-hour periods. The survey is currently being validated.

Participants will be asked to complete the Oxford Happiness Questionnaire (OHQ) at baseline, Months 3 and 12. 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).

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).

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).

The Scale of Positive and Negative Experience (SPANE) is a brief 12-item scale, with six items corresponding to positive emotions and six items corresponding to negative emotions. Each item is scored on a scale ranging from 1 to 5, where 1 represents "very rarely or never" and 5 represents "very often or always." The positive and negative scales are scored separately and each range from 6 to 30. The two scores can also be combined as a scale of balanced affect. Internal consistency is good (ranging from 0.81-0.89 across the scales), as is temporal stability (0.62-0.68). The SPANE has performed well in terms of convergent validity with other measures of emotion, well-being, happiness, and life satisfaction.

The SPANE is a brief 12-item scale, with six items corresponding to positive emotions and six items corresponding to negative emotions. Each item is scored on a scale ranging from 1 to 5, where 1 represents "very rarely or never" and 5 represents "very often or always." The positive and negative scales are scored separately and each range from 6 to 30. The two scores can also be combined as a scale of balanced affect. Internal consistency is good (ranging from 0.81-0.89 across the scales), as is temporal stability (0.62-0.68). The SPANE has performed well in terms of convergent validity with other measures of emotion, well-being, happiness, and life satisfaction.

The Health Promoting Lifestyle Profile II (HPLP-II) is a 52-item instrument measuring self-initiated health behaviors that serve to maintain or enhance the level of self-actualization and wellness. Included are six subscales: physical activity, spiritual growth, health responsibility, interpersonal relations, nutrition, and stress management. It is self-administered and uses a 4-point response format yielding a score for overall health-promoting lifestyle which is obtained by calculating a mean of the individual's responses to all 52 items. Similarly, subscale scores are obtained by calculating a mean of the responses to subscale items. Scores range from 1 = Never to 4 = Routinely, with a higher score corresponding to a more health-promoting lifestyle.

The Health Promoting Lifestyle Profile II (HPLP-II) is a 52-item instrument measuring self-initiated health behaviors that serve to maintain or enhance the level of self-actualization and wellness. Included are six subscales: physical activity, spiritual growth, health responsibility, interpersonal relations, nutrition, and stress management. It is self-administered and uses a 4-point response format yielding a score for overall health-promoting lifestyle which is obtained by calculating a mean of the individual's responses to all 52 items. Similarly, subscale scores are obtained by calculating a mean of the responses to subscale items. Scores range from 1 = Never to 4 = Routinely, with a higher score corresponding to a more health-promoting lifestyle.

Flexibility will be measured using the sit-and-reach test. They will then sit on the floor with their legs outstretched in front of them and their feet perpendicular to the floor (toes facing up). A vertical 12 inch box will be placed against their feet. The participant will then be asked to place one hand over the other such that the tops of their two middle fingers will be on top of one another. Finally, the participant will be instructed to slowly stretch forward and slide their fingers along the box as far as possible. A ruler is used to measure the distance they can reach. This test is repeated three times and the best score will be retained.

Flexibility will be measured using the sit-and-reach test. They will then sit on the floor with their legs outstretched in front of them and their feet perpendicular to the floor (toes facing up). A vertical 12 inch box will be placed against their feet. The participant will then be asked to place one hand over the other such that the tops of their two middle fingers will be on top of one another. Finally, the participant will be instructed to slowly stretch forward and slide their fingers along the box as far as possible. A ruler is used to measure the distance they can reach. This test is repeated three times and the best score will be retained.

Aerobic stamina will be measured using the six minute walk test and the one-minute sit to stand test. 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 are asked to walk at a brisk, yet comfortable pace for a total of 6 minutes. Distance covered in 6 minutes, pre and post perceived exertion and breathlessness and post test pulse are measured.

Aerobic stamina will be measured using the six minute walk test and the one-minute sit to stand test. 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 are asked to walk at a brisk, yet comfortable pace for a total of 6 minutes. Distance covered in 6 minutes, pre and post perceived exertion and breathlessness and post test pulse are measured.

Exercise capacity will be measured using the one-minute sit to stand test. The test measures the number of times a participant can rise from a seated position with arms crossed over chest during a one minute period.

Exercise capacity will be measured using the one-minute sit to stand test. The test measures the number of times a participant can rise from a seated position with arms crossed over chest during a one minute period.