- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04487158
Integrating Small Changes and Positive Psychology to Improve Treatment Readiness: A Weight Loss Trial (INSPIRE)
July 22, 2020 updated by: Lesley Lutes, University of British Columbia
Integrating Small Changes and Positive Psychology to Improve Treatment Readiness: A 12 Month Randomized Controlled Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1V2J8
- University of British Columbia Okanagan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female between the ages of 25 to 75
- BMI between 30 and 45
- Not currently participating in any other weight management programs
- Self-reports wanting to lose weight
- Willing to follow recommendations in the study protocol and attend weekly group intervention for 12 weeks and a 3-month follow-up group (one in-person group per month and one phone call per month)
- Ability to attend 4 assessment appointments over the course of the study period (at baseline, 3-months, 6-months, 12-months).
- Willing to be randomized into any of the two study arms and willing to adhere to guidelines and recommendations associated with the study arm they are randomized into
Exclusion Criteria:
- Cannot commit to weekly group times. Participants must be available for at least one group time of each intervention arm in order to be eligible to participate.
- Participated in a weight loss intervention in the past six months
- Participants who are pregnant (or less than 6 months post partum) or planning to become pregnant in the next 12 months
- Weight loss of > 5kg (~11 lb) in the previous 6 months
- History of, or current, clinically diagnosed eating disorder or exhibiting clinical symptoms of an eating disorder but undiagnosed (EDE-Q ≥ 4.0 unless clinical judgement indicates otherwise)
- Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (as measured by the PAR-Q+) where a doctor's note is not provided
- Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg
- If any of the following medical conditions are present: Insulin dependent diabetes; Previous surgical procedure for weight loss; Major surgery within the previous 6 months; A history of heart problems (e.g., angina, bypass surgery, myocardial infarction) within the previous 6 months; Implanted cardiac defibrillator or pacemaker; Currently (or within the past 5 years) being treated for cancer; Inflammatory Bowel Disease (i.e., chronic inflammatory gastrointestinal disease such as Crohn's Disease or Ulcerative Colitis); Chronic Pain (e.g., fibromyalgia) that would prevent the participant from engaging in physical activity
- The participant is currently experiencing elevated symptoms of depression
- The participant is planning to move within the study period
- The participant consumes more than 14 alcoholic drinks per week or more than 3 drinks per day
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Small Changes
|
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.
|
Experimental: INSPIRE
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline weight (self-report)
Time Frame: 3 months
|
(kg)
|
3 months
|
Change from baseline weight (self-report)
Time Frame: 6 months
|
(kg)
|
6 months
|
Change from baseline weight
Time Frame: 9 months
|
(kg)
|
9 months
|
Change from baseline weight
Time Frame: 12 months
|
(kg)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline on the Satisfaction with Life Scale
Time Frame: 3 months
|
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
Time Frame: 6 months
|
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
Time Frame: 12 months
|
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
Time Frame: 3 months
|
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)
Time Frame: 6 months
|
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)
Time Frame: 12 months
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Waist Circumference
Time Frame: 9 months
|
(cm)
|
9 months
|
Change from Baseline in Waist Circumference
Time Frame: 12 months
|
(cm)
|
12 months
|
Change from Baseline in Blood Pressure
Time Frame: 9 months
|
Systolic and Diastolic Blood Pressure
|
9 months
|
Change from Baseline in Blood Pressure
Time Frame: 12 months
|
Systolic and Diastolic Blood Pressure
|
12 months
|
Change from Baseline in Heart Rate
Time Frame: 9 months
|
9 months
|
|
Change from Baseline in Heart Rate
Time Frame: 12 months
|
12 months
|
|
Change from Baseline on the Self-Compassion Scale
Time Frame: 3 months
|
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
Time Frame: 6 months
|
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
Time Frame: 12 months
|
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
Time Frame: 3 months
|
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
Time Frame: 6 months
|
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
Time Frame: 12 months
|
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
Time Frame: 3 months
|
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
Time Frame: 6 months
|
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
Time Frame: 12 months
|
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
Time Frame: 3 months
|
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
Time Frame: 6 months
|
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
Time Frame: 12 months
|
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
Time Frame: 3 months
|
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
Time Frame: 6 months
|
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
Time Frame: 12 months
|
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
Time Frame: 3 months
|
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
Time Frame: 6 months
|
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
Time Frame: 12 months
|
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
Time Frame: 3 months
|
Step count from pedometers will be recorded daily and averaged across each week.
|
3 months
|
Change from Baseline on the Body Shape Questionnaire
Time Frame: 3 months
|
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
Time Frame: 6 months
|
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
Time Frame: 12 months
|
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
Time Frame: 9 months
|
Resting Metabolic Rate will be reported as kcal/day measured by indirect calorimetry
|
9 months
|
Change from Baseline in Resting Metabolic Rate
Time Frame: 12 months
|
Resting Metabolic Rate will be reported as kcal/day measured by indirect calorimetry
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lesley Lutes, PhD, University of British Columbia- Okanagan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 22, 2019
Primary Completion (Anticipated)
February 1, 2021
Study Completion (Anticipated)
February 1, 2021
Study Registration Dates
First Submitted
June 10, 2020
First Submitted That Met QC Criteria
July 22, 2020
First Posted (Actual)
July 27, 2020
Study Record Updates
Last Update Posted (Actual)
July 27, 2020
Last Update Submitted That Met QC Criteria
July 22, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- H19-02665
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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