ObesityINSPIRENCT04487158
Integrating Small Changes and Positive Psychology to Improve Treatment Readiness: A Weight Loss Trial
A study testing Small Changes and INSPIRE in people with Obesity, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Small Changes and INSPIRE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 22 Nov 2019to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia Okanagan
Kelowna, British Columbia, V1V2J8
About this study
Official title: 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.
Read the 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).
- Conditions
- Obesity
- Being tested
- Small Changes, INSPIRE
- Keywords
- Behavioral Intervention, Psychological Intervention, Weight Management
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small ChangesBehavioural
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.
INSPIREBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Small Changes | Active comparator | Not described Receives: Behavioral: Small Changes |
| INSPIRE | Experimental | Not described Receives: Behavioral: INSPIRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline weight (self-report)
(kg)
Measured: 3 months
Change from baseline weight (self-report)
(kg)
Measured: 6 months
Change from baseline weight
(kg)
Measured: 9 months
Change from baseline weight
(kg)
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 3 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start22 Nov 2019
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lesley Lutes, University of British Columbia
- Investigators
- Lesley Lutes, PhD, Principal investigator, University of British Columbia- Okanagan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487158
- Sponsor's protocol ID
- H19-02665
- Acronym
- INSPIRE
- Status last verified
- Jul 2020
- First submitted
- 10 Jun 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Small Changes and Positive Psychology to Improve Treatment Readiness: A 12 Month Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04487158
- Acronym / sponsor ID
- INSPIRE / H19-02665
- Conditions
- Obesity
- Keywords
- Behavioral Intervention, Psychological Intervention, Weight Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small Changes | Active comparator | Behavioral: Small Changes |
| INSPIRE | Experimental | Behavioral: INSPIRE |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small ChangesThe 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. | Behavioural | Small Changes |
| INSPIREThe 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. | Behavioural | INSPIRE |
Primary outcome
Change from baseline weight (self-report)
Time frame: 3 months
(kg)
Change from baseline weight (self-report)
Time frame: 6 months
(kg)
Change from baseline weight
Time frame: 9 months
(kg)
Change from baseline weight
Time frame: 12 months
(kg)
6 secondary outcomes
Change from Baseline on the Satisfaction with Life Scale
Time frame: 3 months
Change from Baseline on the Satisfaction with Life Scale
Time frame: 6 months
Change from Baseline on the Satisfaction with Life Scale
Time frame: 12 months
Change from Baseline on the Scale of Positive and Negative Experiences
Time frame: 3 months
Change from Baseline on the Scale of Positive and Negative Experiences (SPANE)
Time frame: 6 months
Change from Baseline on the Scale of Positive and Negative Experiences (SPANE)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesley Lutes, PhD principal investigator
University of British Columbia- Okanagan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small Changes and INSPIRE in people with Obesity, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline weight (self-report) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.