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Enrolling by Invitation

NCT Number: NCT07404150

Lifestyle Program Focused on Nourishment, Well-Being, and 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.

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Key information

Age range

35 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Symphony of Health Connections

Calgary, Alberta, T3G4L9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lifestyle change program

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Heather Conradson

Other

Collaborators

  • Novo Nordisk A/S
  • Symphony of Health Connections

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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