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The study is designed to compare short- and long-term changes in body weight (kg) and subjective well-being in adult females with obesity who have been randomized to receive one of two 6-month treatment conditions: INSPIRE or Small Changes. The Small Changes approach is an evidence-based behavioural weight management program that uses relative and modest changes in nutrition and physical activity to produce a caloric deficit. The INSPIRE program is a modification of the Small Changes program that spends the first four weeks on improving well-being via psychological interventions.
Rates of obesity continues to rise in Canada and worldwide, which is related to the presence and increased severity of multiple co-morbid illnesses as well as a reduction in overall quality and quantity of life. Traditional behavioural interventions have demonstrated efficacy in producing initial weight loss; however, a continued challenge for these programs is long-term weight loss maintenance. The Small Changes program is an alternative approach to weight loss that encourages modest changes to nutrition and physical activity that are sustainable long-term. Although promising, this approach has failed to consistently demonstrate clinically significant weight loss. It has been suggested that psychological factors, such as low levels of subjective well-being (negative affect, positive affect, and life satisfaction), may work in opposition of an individual's weight management goals. Thus, the integration of psychological interventions with a Small Changes approach has the potential to improve well-being and weight loss concurrently. Based on previous research, psychological interventions may be effectively utilized if they are implemented at the beginning of an intervention where early changes in well-being promote greater adherence to health behaviour change. To date, no behavioural intervention that integrates psychological approaches at treatment outset has been evaluated. The primary aim of the study is to determine the feasibility, acceptability, and efficacy of a novel group-based integrative behavioural and psychological intervention (INSPIRE) on change in weight and subjective well-being outcomes compared to an evidence-based behavioural intervention for weight loss (Small Changes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Small Changes | Active Comparator |
| |
| INSPIRE | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Small Changes | Behavioral | The Small Changes program is an evidence-based 6-month weight-management program. The program runs weekly for 3 months followed by by-weekly contact for 3-months (1x in-person group and 1x phone call). This program uses behaviour change strategies to help with weight loss. The Small Changes approach is different from traditional dieting programs because it encourages modest changes to diet and physical activity which are not overly taxing to maintain. Participants are asked to reduce their nutritional intake by 200-400 calories per day. You will also be asked to increase their daily step count by 2000-3000 steps. Weekly intervention topics include: Monitoring, Nutrition, Physical Activity, Breaking the Chain, External Cues, Mindful Eating, Body Image, Stress, Sleep, Social Support, Social Eating, and the Stoplight Guide. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline weight (self-report) | (kg) | 3 months |
| Change from baseline weight (self-report) | (kg) | 6 months |
| Change from baseline weight | (kg) | 9 months |
| Change from baseline weight | (kg) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline on the Satisfaction with Life Scale | The Satisfaction with Life Scale is 5-item questionnaire used to assess life satisfaction which is a component of subjective well-being. Total scores range from 5 to 35 with higher scores indicating greater life satisfaction. | 3 months |
| Change from Baseline on the Satisfaction with Life Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Waist Circumference | (cm) | 9 months |
| Change from Baseline in Waist Circumference | (cm) | 12 months |
Inclusion Criteria:
Exclusion Criteria:
Self-identify as female
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| Name | Affiliation | Role |
|---|---|---|
| Lesley Lutes, PhD | University of British Columbia- Okanagan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia Okanagan | Kelowna | British Columbia | V1V2J8 | Canada |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| INSPIRE | Behavioral | The INSPIRE program is a modification to the Small Changes program. It combines elements of positive psychology and behaviour change to help with weight loss. The first four weeks of the program are oriented towards improving well-being and include topics such as values, self-compassion/mindfulness, character strengths, and gratitude. The remaining 8 weeks mirrors the Small Changes program in making modest changes to diet and physical activity to achieve weight loss. Participants are asked to reduce their nutritional intake by 200-400 calories per day. Participants will also be asked to increase their daily step count by 2000-3000 steps. |
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The Satisfaction with Life Scale is 5-item questionnaire used to assess life satisfaction which is a component of subjective well-being. Total scores range from 5 to 35 with higher scores indicating greater life satisfaction. |
| 6 months |
| Change from Baseline on the Satisfaction with Life Scale | The Satisfaction with Life Scale is 5-item questionnaire used to assess life satisfaction which is a component of subjective well-being. Total scores range from 5 to 35 with higher scores indicating greater life satisfaction. | 12 months |
| Change from Baseline on the Scale of Positive and Negative Experiences | The Scale of Positive and Negative Experiences 12-item self-report measure that will be used to measure two components of subjective well-being (positive affect and negative affect). The 12-items load onto two sub-scales: one pertaining to Positive Affect and the other pertaining to Negative Affect. Both subscales range from 6 to 30. Higher scores on these two sub-scales indicate greater experiences of either positive or negative affect states (i.e., higher scores on the SPANE-PA scale indicates greater frequency of experiencing positive emotions). | 3 months |
| Change from Baseline on the Scale of Positive and Negative Experiences (SPANE) | The Scale of Positive and Negative Experiences is 12-item self-report measure that will be used to measure two components of subjective well-being (positive affect and negative affect). The 12-items load onto two sub-scales: one pertaining to Positive Affect and the other pertaining to Negative Affect. Both subscales range from 6 to 30. Higher scores on these two sub-scales indicate greater experiences of either positive or negative affect states (i.e., higher scores on the SPANE-PA scale indicates greater frequency of experiencing positive emotions). | 6 months |
| Change from Baseline on the Scale of Positive and Negative Experiences (SPANE) | The Scale of Positive and Negative Experiences is 12-item self-report measure that will be used to measure two components of subjective well-being (positive affect and negative affect). The 12-items load onto two sub-scales: one pertaining to Positive Affect and the other pertaining to Negative Affect. Both subscales range from 6 to 30. Higher scores on these two sub-scales indicate greater experiences of either positive or negative affect states (i.e., higher scores on the SPANE-PA scale indicates greater frequency of experiencing positive emotions). | 12 months |
| Change from Baseline in Blood Pressure | Systolic and Diastolic Blood Pressure | 9 months |
| Change from Baseline in Blood Pressure | Systolic and Diastolic Blood Pressure | 12 months |
| Change from Baseline in Heart Rate | 9 months |
| Change from Baseline in Heart Rate | 12 months |
| Change from Baseline on the Self-Compassion Scale | The Self-Compassion Scale is a 26-item self-report measure which will be used to measure how an individual responds and acts towards themselves during difficult times. Total score ranges from 5 to 30 with higher scores indicating greater self-compassion. | 3 months |
| Change from Baseline on the Self-Compassion Scale | The Self-Compassion Scale is a 26-item self-report measure which will be used to measure how an individual responds and acts towards themselves during difficult times. Total score ranges from 5 to 30 with higher scores indicating greater self-compassion. | 6 months |
| Change from Baseline on the Self-Compassion Scale | The elf-Compassion Scale is a 26-item self-report measure which will be used to measure how an individual responds and acts towards themselves during difficult times. Total score ranges from 5 to 30 with higher scores indicating greater self-compassion. | 12 months |
| Change from Baseline on the New General Self-Efficacy Scale | The New General Self-Efficacy is an 8-item self-report questionnaire that will be used to measure general self-efficacy. Total scores range from 8 to 40 with higher scores indicating greater general self-efficacy. | 3 months |
| Change from Baseline on the New General Self-Efficacy Scale | The New General Self-Efficacy is an 8-item self-report questionnaire that will be used to measure general self-efficacy. Total scores range from 8 to 40 with higher scores indicating greater general self-efficacy. | 6 months |
| Change from Baseline on the New General Self-Efficacy Scale | The New General Self-Efficacy is an 8-item self-report questionnaire that will be used to measure general self-efficacy. Total scores range from 8 to 40 with higher scores indicating greater general self-efficacy. | 12 months |
| Change from Baseline on the Self-Efficacy for Exercise Scale | The Self-Efficacy for Exercise Scale is a 9-item self-report questionnaire that will be used to measure self-efficacy for exercise. Total scores range from 0 to 90 with higher scores representative of greater exercise-related self-efficacy. | 3 months |
| Change from Baseline on the Self-Efficacy for Exercise Scale | The Self-Efficacy for Exercise Scale is a 9-item self-report questionnaire that will be used to measure self-efficacy for exercise. Total scores range from 0 to 90 with higher scores representative of greater exercise-related self-efficacy. | 6 months |
| Change from Baseline on the Self-Efficacy for Exercise Scale | The Self-Efficacy for Exercise Scale is a 9-item self-report questionnaire that will be used to measure self-efficacy for exercise. Total scores range from 0 to 90 with higher scores representative of greater exercise-related self-efficacy. | 12 months |
| Change from Baseline on the Weight Efficacy Lifestyle Questionnaire Short-Form | The Weight Efficacy Lifestyle Questionnaire Short-Form will be used to measure a specific form of self-efficacy related to eating habits. The WEL-SF is an 8-item measure with total scores ranging from 0 to 80 where higher scores are indicative of greater self-efficacy for eating habits. | 3 months |
| Change from Baseline on the Weight Efficacy Lifestyle Questionnaire Short-Form | The Weight Efficacy Lifestyle Questionnaire Short-Form will be used to measure a specific form of self-efficacy related to eating habits. The WEL-SF is an 8-item measure with total scores ranging from 0 to 80 where higher scores are indicative of greater self-efficacy for eating habits. | 6 months |
| Change from Baseline on the Weight Efficacy Lifestyle Questionnaire Short-Form | The Weight Efficacy Lifestyle Questionnaire Short-Form will be used to measure a specific form of self-efficacy related to eating habits. The WEL-SF is an 8-item measure with total scores ranging from 0 to 80 where higher scores are indicative of greater self-efficacy for eating habits. | 12 months |
| Change from Baseline on the Three Factor Eating Questionnaire-Revised | The Three Factor Eating Questionnaire-Revised is an 18-item self-report measure of the cognitive and behavioural components of eating across three factors: Cognitive Restraint, Uncontrolled Eating, and Emotional Eating. Each subscale ranges from 1 to 4 (mean of all item on each subscale) with higher scores indicating greater endorsement of the subscale domain. Higher scores on the Cognitive Restraint represent greater cognitive restraint. Higher scores on the Uncontrolled subscale represent greater experiences with uncontrolled eating. Higher scores on the Emotional Eating subscale represent greater experiences with emotional eating. | 3 months |
| Change from Baseline on the Three Factor Eating Questionnaire-Revised | The Three Factor Eating Questionnaire-Revised is an 18-item self-report measure of the cognitive and behavioural components of eating across three factors: Cognitive Restraint, Uncontrolled Eating, and Emotional Eating. Each subscale ranges from 1 to 4 (mean of all item on each subscale) with higher scores indicating greater endorsement of the subscale domain. Higher scores on the Cognitive Restraint represent greater cognitive restraint. Higher scores on the Uncontrolled subscale represent greater experiences with uncontrolled eating. Higher scores on the Emotional Eating subscale represent greater experiences with emotional eating. | 6 months |
| Change from Baseline on the Three Factor Eating Questionnaire-Revised | The Three Factor Eating Questionnaire-Revised is an 18-item self-report measure of the cognitive and behavioural components of eating across three factors: Cognitive Restraint, Uncontrolled Eating, and Emotional Eating. Each subscale ranges from 1 to 4 (mean of all item on each subscale) with higher scores indicating greater endorsement of the subscale domain. Higher scores on the Cognitive Restraint represent greater cognitive restraint. Higher scores on the Uncontrolled subscale represent greater experiences with uncontrolled eating. Higher scores on the Emotional Eating subscale represent greater experiences with emotional eating. | 12 months |
| Change from Baseline on the Food Cravings Inventory | The Food Cravings Inventory is a 33-item self-report measure of food cravings. Total score ranges from 33 to 165 with higher scores indicative of greater food cravings. | 3 months |
| Change from Baseline on the Food Cravings Inventory | The Food Cravings Inventory is a 33-item self-report measure of food cravings. Total score ranges from 33 to 165 with higher scores indicative of greater food cravings. | 6 months |
| Change from Baseline on the Food Cravings Inventory | The Food Cravings Inventory is a 33-item self-report measure of food cravings. Total score ranges from 33 to 165 with higher scores indicative of greater food cravings. | 12 months |
| Change from Baseline on Objective Mean Step Count across 7 days | Step count from pedometers will be recorded daily and averaged across each week. | 3 months |
| Change from Baseline on the Body Shape Questionnaire | The Body Shape Questionnaire is a 34-item self-report questionnaire of cognitively-based body dissatisfaction. Total scores range from 34 to 170 with higher scores indicative of greater body dissatisfaction. | 3 months |
| Change from Baseline on the Body Shape Questionnaire | The Body Shape Questionnaire is a 34-item self-report questionnaire of cognitively-based body dissatisfaction. Total scores range from 34 to 170 with higher scores indicative of greater body dissatisfaction. | 6 months |
| Change from Baseline on the Body Shape Questionnaire | The Body Shape Questionnaire is a 34-item self-report questionnaire of cognitively-based body dissatisfaction. Total scores range from 34 to 170 with higher scores indicative of greater body dissatisfaction. | 12 months |
| Change from Baseline in Resting Metabolic Rate | Resting Metabolic Rate will be reported as kcal/day measured by indirect calorimetry | 9 months |
| Change from Baseline in Resting Metabolic Rate | Resting Metabolic Rate will be reported as kcal/day measured by indirect calorimetry | 12 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |