Clinical trial

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

Invitation only · Not applicable · 1 countries · Registry ID NCT07404150

Invitation onlyNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age35 Years to 75 Years

SexFemale

Healthy volunteersAccepted

ConditionObesity and Cardiovascular Risk

Full registry criteria

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

Treatments and study arms

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

Percent weight change and internalized weight bias (WBIS)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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Symphony of Health Connections🇨🇦 Calgary, Alberta, Canada

Open map