Obesity and Cardiovascular RiskNCT07404150
Lifestyle Program Focused on Nourishment, Well-Being, and Health Behaviors in Women With Obesity
An observational study of Obesity and Cardiovascular Risk, run by Heather Conradson at 1 site in Canada.
Trial summary
Women, Weight and Well-Being is a 12-month research study looking at how a supportive lifestyle program may help women whose weight increases their risk for heart disease. The objective is to evaluate whether taking part in the program is linked with changes in: body weight and waist size; blood pressure and bloodwork… Read more about this study
- Who is it for?
- Ages 35 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity and Cardiovascular Risk
- What is being tested?
- lifestyle change program
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jan 2026to 15 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women aged 35-75 years whose weight poses a CVD risk.
Who may be able to join
- • Ability to provide informed consent before any study-related activities
- Female
- Age between 35 and 75 years
- BMI ≥ 30 kg/m² with waist circumference ≥ 88 cm or BMI ≥ 27 kg/m² with obesity-related health conditions consistent with Edmonton Obesity Staging System Stage ≥ 1.
- Willingness to engage in a 12-month interdisciplinary lifestyle program
- Ability to attend group sessions (in person or virtually) and complete follow-up visits
- Alberta resident with Alberta Health Care insurance
- Sufficient proficiency in English to engage with group material and communications
Who cannot join
- Pregnant, breastfeeding, or planning to become pregnant during the study period
- Diagnosis of type 1 diabetes
- Life-limiting illness or severe medical condition where weight loss would not be clinically appropriate (e.g., advanced cancer, end-stage organ failure); clinical judgment will be used to assess suitability
- Severe psychiatric illness or cognitive impairment that would interfere with participation in group sessions or study procedures
- Current participation in another weight management or investigational study
- Inability to comply with study procedures due to logistical, medical, or language barriers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Women, Weight, and Well-Being: An Observational Study of an Interdisciplinary Lifestyle Program With or Without GLP-1 Therapy to Support Intentional Weight Loss, Reduce Internalized Weight Bias, and Improve Positive Health Behaviors in Women With Obesity.
Women, Weight and Well-Being is a 12-month research study looking at how a supportive lifestyle program may help women whose weight increases their risk for heart disease.
The objective is to evaluate whether taking part in the program is linked with changes in: body weight and waist size; blood pressure and bloodwork related to heart health (such as cholesterol and A1C); health habits (movement, eating patterns, sleep); well-being and how women feel about their bodies, including the effects of weight stigma.
Read more
About 60 women aged 35-75 will take part. Participants will attend group sessions and have one-on-one support from a nurse, dietitian, and kinesiologist. Some participants may also use GLP-1 medication (a type of medication that can support weight loss) as part of their regular medical care, if appropriate. The study does not assign medication. Outcomes will be observed over time.
Information will be collected at the start of the program, at 6 months, and at 12 months using measurements (such as weight, waist, blood pressure), routine lab results, and questionnaires about health and well-being.
Read the detailed description
Women with obesity face a higher risk of cardiovascular disease and cardiometabolic complications, yet this risk is frequently under addressed, creating a gap in cardiovascular care. Compounding this risk are the psychological impacts of weight stigma, internalized weight bias (IWB), the internal adoption of society's negative stereotypes about body weight, which is more prevalent among women and linked to chronic stress, healthcare avoidance, disruptions in health-promoting behaviours, and increased morbidity and mortality.
A 12-month observational study addresses these gaps by offering and assessing the impact of an interdisciplinary lifestyle program on weight loss, cardiovascular, and psychological outcomes in women whose weight poses a cardiovascular disease (CVD) risk. It integrates medical, nutritional, exercise and psychological support through group-based education, individualized care, and the option to use GLP-1 therapy. The program offers stigma-free, relationship-centred support grounded in the biology of adiposity and the importance of self-compassion, nourishing and non-restrictive nutrition, movement, sleep, and emotional well-being.
This study will enroll 60 women aged 35-75 years whose weight poses a CVD risk. Eligibility includes BMI ≥ 30 kg/m² with waist circumference >88 cm or BMI ≥ 27 kg/m² obesity-related health conditions consistent with Edmonton Obesity Staging System Stage ≥ 1. Participants may choose a lifestyle-only approach or add GLP-1 therapy, with nurse-led titration and monitoring.
The program includes three phases: Phase 1 (Weeks 0 to 6) offers weekly group sessions and individual visits; Phase 2 (Weeks 7 to 24) provides biweekly sessions and a midpoint assessment; and Phase 3 (Months 7 to 12) delivers monthly support and long-term follow-up. Collaborating with the participant's cardiologist or primary care provider, an interdisciplinary team (RN, RD, Kinesiologist) will provide group and one-on-one support. RN or RD check-ins occur biweekly during the first six months and monthly thereafter, with RN-led support for medication titration as needed.
Data including weight, waist circumference, BP, lipids, HbA1C, exercise capacity (DASI, grip strength, BODY-Q physical function), dietary patterns (24hr Dietary Recall, Mediterranean Diet Score, BODY-Q dietary behavior), food noise (FNQ), psychological well-being (PERMA, EQ-5D-5L, BODY-Q social function, Psychological function, SCS-SF), sleep (STOP-BANG) and internalized weight bias (WBIS) will be collected at baseline, 6, and 12 months. Focus groups will explore participant experience. The findings will inform women-centred care by evaluating whether this interdisciplinary program promotes positive health behaviours, enhances well-being, and improves cardiometabolic risk.
- Conditions
- Obesity and Cardiovascular Risk
- Being tested
- lifestyle change program
- Keywords
- obesity, women, cardiovascular risk
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle change programOther
21 Group classes provided by interdisciplinary team (RN,RD,KIN); BI-weekly individual follow-up for first 6 months then monthly in addition to classes
| Study group | Role | What they receive |
|---|---|---|
| Women aged 35-75 years whose weight poses a CVD risk | Eligibility includes BMI ≥ 30 kg/m² with waist circumference > 88 cm, or BMI ≥ 27 kg/m² with obesity-related health conditions consistent with Edmonton Obesity Staging System (EOSS) stage 1 or higher. Participants take part in a 12-month, women-focused lifestyle program delivered in groups, with added individual support. The program includes 21 group classes over 12 months, plus brief check-ins every two weeks for the first 6 months and then monthly until 12 months. Sessions focus on practical, sustainable changes related to nourishment (not restrictive dieting), intentional movement for health, and emotional well-being (e.g., self-compassion skills, sleep support, and mindfulness or meditation strategies). The program emphasizes the biology of weight gain and provides support in a stigma-free, non-judgmental way. Some participants may also use GLP-1 medication as part of their usual medical care. Receives: Other: lifestyle change program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent weight change and internalized weight bias (WBIS)
In addition to weight change we will measure , waist circumference, BP, lipids, HbA1C, exercise capacity (DASI, grip strength, BODY-Q physical function), dietary patterns (24hr Dietary Recall, Mediterranean Diet Score, BODY-Q dietary behavior), food noise, psychological well-being (PERMA, EQ-5D-5L, BODY-Q social function, Psychological function, SCS-SF), sleep (STOP-BANG) will be collected at baseline, 6, and 12 months. Focus groups will explore participant experience.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start12 Jan 2026
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Cardiovascular RiskStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heather Conradson
- Sponsor type
- University, hospital or other
- Collaborators
- Symphony of Health Connections, Novo Nordisk A/S
- Responsible party
- Sponsor-investigator, Heather Conradson, Symphony of Health Connections
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404150
- Sponsor's protocol ID
- HREBA-Protocol-CHC 25-00092
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2026
- Last updated
- 6 Apr 2026
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women, Weight, and Well-Being: An Observational Study of an Interdisciplinary Lifestyle Program With or Without GLP-1 Therapy to Support Intentional Weight Loss, Reduce Internalized Weight Bias, and Improve Positive Health Behaviors in Women With Obesity.
- ClinicalTrials.gov ID
- NCT07404150
- Acronym / sponsor ID
- HREBA-Protocol-CHC 25-00092
- Conditions
- Obesity and Cardiovascular Risk
- Keywords
- obesity, women, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Heather ConradsonUniversity, hospital or other
- Collaborators
- Symphony of Health Connections, Novo Nordisk A/S
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 11 Feb 2026 (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.
Women, Weight and Well-Being is a 12-month research study looking at how a supportive lifestyle program may help women whose weight increases their risk for heart disease.
The objective is to evaluate whether taking part in the program is linked with changes in: body weight and waist size; blood pressure and bloodwork related to heart health (such as cholesterol and A1C); health habits (movement, eating patterns, sleep); well-being and how women feel about their bodies, including the effects of weight stigma.
About 60 women aged 35-75 will take part. Participants will attend group sessions and have one-on-one support from a nurse, dietitian, and kinesiologist. Some participants may also use GLP-1 medication (a type of medication that can support weight loss) as part of their regular medical care, if appropriate. The study does not assign medication. Outcomes will be observed over time.
Information will be collected at the start of the program, at 6 months, and at 12 months using measurements (such as weight, waist, blood pressure), routine lab results, and questionnaires about health and well-being.
Detailed description
Women with obesity face a higher risk of cardiovascular disease and cardiometabolic complications, yet this risk is frequently under addressed, creating a gap in cardiovascular care. Compounding this risk are the psychological impacts of weight stigma, internalized weight bias (IWB), the internal adoption of society's negative stereotypes about body weight, which is more prevalent among women and linked to chronic stress, healthcare avoidance, disruptions in health-promoting behaviours, and increased morbidity and mortality.
A 12-month observational study addresses these gaps by offering and assessing the impact of an interdisciplinary lifestyle program on weight loss, cardiovascular, and psychological outcomes in women whose weight poses a cardiovascular disease (CVD) risk. It integrates medical, nutritional, exercise and psychological support through group-based education, individualized care, and the option to use GLP-1 therapy. The program offers stigma-free, relationship-centred support grounded in the biology of adiposity and the importance of self-compassion, nourishing and non-restrictive nutrition, movement, sleep, and emotional well-being.
This study will enroll 60 women aged 35-75 years whose weight poses a CVD risk. Eligibility includes BMI ≥ 30 kg/m² with waist circumference >88 cm or BMI ≥ 27 kg/m² obesity-related health conditions consistent with Edmonton Obesity Staging System Stage ≥ 1. Participants may choose a lifestyle-only approach or add GLP-1 therapy, with nurse-led titration and monitoring.
The program includes three phases: Phase 1 (Weeks 0 to 6) offers weekly group sessions and individual visits; Phase 2 (Weeks 7 to 24) provides biweekly sessions and a midpoint assessment; and Phase 3 (Months 7 to 12) delivers monthly support and long-term follow-up. Collaborating with the participant's cardiologist or primary care provider, an interdisciplinary team (RN, RD, Kinesiologist) will provide group and one-on-one support. RN or RD check-ins occur biweekly during the first six months and monthly thereafter, with RN-led support for medication titration as needed.
Data including weight, waist circumference, BP, lipids, HbA1C, exercise capacity (DASI, grip strength, BODY-Q physical function), dietary patterns (24hr Dietary Recall, Mediterranean Diet Score, BODY-Q dietary behavior), food noise (FNQ), psychological well-being (PERMA, EQ-5D-5L, BODY-Q social function, Psychological function, SCS-SF), sleep (STOP-BANG) and internalized weight bias (WBIS) will be collected at baseline, 6, and 12 months. Focus groups will explore participant experience. The findings will inform women-centred care by evaluating whether this interdisciplinary program promotes positive health behaviours, enhances well-being, and improves cardiometabolic risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women aged 35-75 years whose weight poses a CVD risk | – | Other: lifestyle change programEligibility includes BMI ≥ 30 kg/m² with waist circumference > 88 cm, or BMI ≥ 27 kg/m² with obesity-related health conditions consistent with Edmonton Obesity Staging System (EOSS) stage 1 or higher. Participants take part in a 12-month, women-focused lifestyle program delivered in groups, with added individual support. The program includes 21 group classes over 12 months, plus brief check-ins every two weeks for the first 6 months and then monthly until 12 months. Sessions focus on practical, sustainable changes related to nourishment (not restrictive dieting), intentional movement for health, and emotional well-being (e.g., self-compassion skills, sleep support, and mindfulness or meditation strategies). The program emphasizes the biology of weight gain and provides support in a stigma-free, non-judgmental way. Some participants may also use GLP-1 medication as part of their usual medical care. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 35-75 years whose weight poses a CVD risk.
Key inclusion criteria (8 listed)
- • Ability to provide informed consent before any study-related activities
Key exclusion criteria (6 listed)
- Pregnant, breastfeeding, or planning to become pregnant during the study period
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 |
|---|---|---|
| lifestyle change program21 Group classes provided by interdisciplinary team (RN,RD,KIN); BI-weekly individual follow-up for first 6 months then monthly in addition to classes | Other | Women aged 35-75 years whose weight poses a CVD risk |
Primary outcome
Percent weight change and internalized weight bias (WBIS)
Time frame: 18 months
In addition to weight change we will measure , waist circumference, BP, lipids, HbA1C, exercise capacity (DASI, grip strength, BODY-Q physical function), dietary patterns (24hr Dietary Recall, Mediterranean Diet Score, BODY-Q dietary behavior), food noise, psychological well-being (PERMA, EQ-5D-5L, BODY-Q social function, Psychological function, SCS-SF), sleep (STOP-BANG) will be collected at baseline, 6, and 12 months. Focus groups will explore participant experience.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Cardiovascular Risk, run by Heather Conradson 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 8 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 6 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percent weight change and internalized weight bias (WBIS) (time frame: 18 months). 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 6 Apr 2026.