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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Small Changes
Behavioral: 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
Behavioral: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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