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

NCT07404150 | Enrolling By Invitation

• 1 other identifier: HREBA-Protocol-CHC 25-00092
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. We want to understand 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 it is right for them. The study does not assign medication. We simply observe outcomes 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.

Conditions

Obesity and Cardiovascular Risk

Keywords

obesity; women; cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Study Arms (1)

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

Interventions

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

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

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heather Conradson: lead
• Symphony of Health Connections: collaborator
• Novo Nordisk A/S: collaborator

Study Sites (1)

Symphony of Health Connections

Calgary, Alberta, T3G4L9, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Nurse Scientist (PhD, RN)

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)