WIN: a Feasibility Study of a Weight-Neutral Health Intervention

The proportion of participants who complete the follow-up examination, defined as answering the 'Mental health component' of the 36-item Short Form survey

The proportion of people who are enrolled as participants (numerator, n) out of all those who passed the initial telephone screening (denominator, N).

Proportion of sessions attended by participants compared to the total number of sessions available

Proportion of sessions attended by participants compared to the total number of sessions available

Proportion of participants that complete all questionnaires required in CID1 and CID2, see list below (all outcomes specified as 'exploratory clinical outcome, questionnaire')

Proportion of participants willing to give blood samples at both CID1 and CID2

Proportion of participants willing to give hair samples at both CID1 and CID2

Proportion of participants willing to wear an actigraphy measuring physical activity. Assessed as the proportion of participants willing to wear and returning the SENS monitor after both CID1 and CID2.

Proportion of participants participating in the physical assessments in both CID1 and CID2, see list below (all outcomes specified as 'exploratory clinical outcome, physical assessment')

Proportion of participants participating in at least one of the optional sessions 'rest and movement'

Proportion of participants participating in at least one of the optional sessions 'competence and strength training'

Proportion of participants participating in at least one of the optional 'support network events'

Proportion of participants who attends at least one online session with the WIN-group therapist

Quality of life, Short Form 36, mental component score (scale from 0-100, higher scores indicate better mental health)

Quality of life, Short Form 36, physical component score (scale from 0-100, higher scores indicate better mental health)

Quality of life, Short Form 36, individual domains (scales from 0-100, higher scores indicate better mental health):

• physical functioning,
• role limitations due to physical health problems,
• bodily pain,
• general health,
• vitality (energy or fatigue),
• social functioning,
• role limitations due to emotional problems,
• mental health (psychological distress and psychological well-being).

Weight Bias Internalization Scale (WBIS-M) score (scale from 1-7, higher scores indicate higher degree of internalized weight bias)

Intuitive Eating Scale measuring participants' ability to rely on internal hunger and satiety cues, reject dieting mentally, and approach eating with body respect. 12 items, each scored 1-5. Minimum value 12, maximum value 60. Higher score reflects more intuitive eating (better outcome).

Eating Disorder Examination Questionnaire (EDE-Q) score (scale from 0 to 6, higher scores indicate higher degree of eating disorder)

Rosenberg Self-Esteem Scale, measuring self-esteem levels as a psychological marker of well-being. 10 items, each scored 1-4. Minimum value 10, maximum value 40. Higher scores indicate higher self-esteem (better outcome).

Body Appreciation Scale 2 (BAS-2), assessing positive body image, focusing on body acceptance and appreciation. 10 items, each scored 1-5. Minimum value 10, maximum value 50. Higher score indicates higher body appreciation (better outcome).

Cantril Ladder Scale, providing a subjective measure of life satisfaction and well-being. Range: 0-10. A ladder stretching from 0 at the bottom (worst possible situation) to 10 at the top (best possible situation). Higher score indicates a more positive evaluation of one´s life (better outcome).

Major Depression Inventory (MDI) (scale from 0-50, higher scores indicate more symptoms of depression)

Perceived Stress Scale (PSS-10), measures perceived stress over the past month. 10 items, each scored 0-4. Minimum value 0, maximum value 40. Higher scores indicating higher perceived stress (worse outcome).

(Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.)

Assessed with activity tracker (SENS), measuring daily movement and exercise patterns (hours/day)

Sleep duration using SENS Motion accelerometers (hours/day)

Chronic stress (hair cortisol as a biomarker of long-term stress exposure)

Systolic and diastolic blood pressure (mmHg)

Pulse rate (beats per minute)

Weight (kg)

Haemoglobin A1c (mmol/mol)

Lipid profile (HDL, LDL, VLDL, total cholesterol and triglycerides) (mmol/L)

Creatinine (umol/L)

Estimated Glomerular Filtration Rate (eGFR) (mL/min/1.73^2)

High-sensitivity C-reactive protein (hsCRP), mg/L

Alanine aminotransferase (ALAT) (unit per liter)

Thyroid-stimulating hormone (x10^-3 IU/L)

Sodium (mmol/L)

Potassium (mmol/L)

Haemoglobin (mmol/L)

25-OH vitamin D (nmol/L)

Proportion of participants that experienced at least one serious adverse event (according to ICH-GCP guidelines)

Proportion of participants that complete all questionnaires required in CID1 and CID2, see list below (all outcomes specified as 'exploratory clinical outcome, questionnaire')