Lifestyle Program Focused on Nourishment, Well-Being, and Health Behaviors in Women With Obesity

March 31, 2026 updated by: Heather Conradson

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.

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

60

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
    • Alberta
      • Calgary, Alberta, Canada, T3G4L9
        • Symphony of Health Connections

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women aged 35-75 years whose weight poses a CVD risk.

Description

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: lifestyle change program
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heather Conradson

Collaborators

Novo Nordisk A/S
Symphony of Health Connections

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)

January 12, 2026

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

September 15, 2027

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREBA-Protocol-CHC 25-00092

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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