SHED-IT Recharge: Evaluation of an online weight loss program for men with low mood.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2019
INTERVENTION: Men in the intervention group will receive the SHED‐IT Recharge Program. This 3‐month program will be based on the SHED‐IT Weight Loss Program for Men, which has been validated in previous RCTs. Given the study is specifically targeting men with overweight/obesity and low mood, the program will be adapted to include additional information and strategies supporting men's mental health, which will be specifically created for this study. As with the SHED‐IT program, SHED‐IT: Recharge will be an eHealth, self‐directed program. As such, participants will complete the program independently in their own home, without the need to engage with a program facilitator. The program will also be ‘gender‐tailored’, targeting both surface structure components (e.g., male images and statistics) and deep‐structure components, which align with men’s preferences and values (e.g., frank and realistic communication, humour). At the point of randomisation, all men in the intervention group will receive: i) The SHED‐IT: Recharge Guide to Physical and Mental Fitness (hardcopy) ii) The SHED‐IT: Recharge Log Book (hardcopy document to complete key program tasks, e.g., weight monitoring), and iii) Access to the SHED‐IT: Recharge Website, which will include a series of weight loss video clips containing non‐prescriptive dietary and exercise advice, brief strength training workout videos (5‐10 minutes), which will be uploaded weekly, and four ‘mental fitness’ modules to be completed over the 3 months. These modules will target evidence‐based cognitive‐behavioural techniques for managing depressive symptoms (e.g., cognitive restructuring, mindfulness, behavioural activation) and will be made available in Weeks 4, 7, 10, and 13 of the program. Each module will take approximately 15‐20 minutes to complete. iv) A pedometer to track physical activity habits v) Weekly motivational text messages Men will also be encouraged to monitor their weight (weekly) and the CONDITION: Diet and Nutrition ‐ Obesity Mental Health ‐ Depression Overweight/Obesity;Depression; ; Overweight/Obesity ; Depression Public Health ‐ Health promotion/education PRIMARY OUTCOME: Depressive Symptoms, measured using the 9‐item Patient Health Questionnaire (PHQ‐9).[Baseline, 3 months post‐baseline (primary endpoint), and 6 months post‐baseline.] Weight (kg) measured in light clothing, without shoes on a digital scale. [Baseline, 3 months post‐baseline (primary endpoint), and 6 months post‐baseline.] ; [Baseline, 3 months post‐baseline, and 6 months post‐baseline.] LDL‐Cholesterol (mmol/l), obtained from a fasting finger prick blood sample analysed using a CardioChek analyser and lipid panel test strips.[Baseline, 3 months post‐baseline, and 6 months post‐baseline. ; ] Triglyceride (mmol/l), obtained from a fasting finger prick blood sample analysed using a CardioChek analyser and lipid panel test strips. ; [Baseline, 3 months post‐baseline, and 6 months post‐baseline. ; ] Waist Circumference, measured level with the umbilicus using a non‐extensible steel tape. [Baseline, 3 months post‐baseline, and 6 months post‐baseline.] INCLUSION CRITERIA: ‐ Male ‐ Aged 18‐70 years old ‐ Overweight or obese (Body Mass Index of 25‐42 kg/m2) ‐ Current depressive symptoms indicated by a PHQ‐9 score greater than or equal to 5 ‐ Own a computer, tablet or smartphone with internet access; ‐ Available to attend three assessment sessions at the University of Newcastle over 6 months. SECONDARY OUTCOME: % Energy from Non‐core Food, measured using the online Australian Eating Survey[Baseline, 3 months post‐baseline, and 6 months post‐baseline.] % time spent in light physical activity, measured via one week of accelerometry using GT3x accelerometers.[Baseline, 3 months post‐baseline, and 6 months post‐baseline.] % time spent in moderate to vigorous physical activity, measured via one week of accelerometery with GT3x accelerometers[Baseline, 3 months post‐baseline, and 6 months post‐baseline.] Anxiety symptoms, measured using the 7‐item Generalised Anxiety Disorder Questionnaire (GAD‐7).[Baseline, 3 months post‐baseline, and 6 months post‐baseline.] Arterial stiffness (augmentation index), measured with the Pulsecor Cardioscope II[Baseline, 3 months post‐baseline, and 6 months post‐baseline.] Average meal portion sizes, measured using portion size photographs from the Dietary Questionnaire for Epidemiological Studies v2[Baseline, 3 months post‐baseline, and 6 months post‐baseline.] Average total kJ/day, measured using the online Australian Eating Survey.[Baseline, 3 months post‐baseline, and 6 months post‐baseline.] Behavioral Activation experiences, measured using the Behavioral Activation for Depression Scale.[Baseline, 3 months post‐baseline and 6 months post‐baseline] Body Fat %, measured using InBody720 bioimpedance machine.[Baseline, 3 months post‐baseline, and 6 months post‐baseline.] Body Mass Index, measured using the standard formula (kg/m2). Height will be measured at baseline using a calibrated stadiometer (stretch stature method).[Baseline, 3 months post‐baseline,. and 6 months post‐baseline.] Brachial blood pressure (diastolic), measured with the Pulsecor Cardioscope II[Baseline, 3 months post‐baseline, and 6 months post‐baseline] Brachial blood pressure (systolic), measured with the Pulsecor Cardioscope II[Baseline, 3 months post‐baseline, and 6 months post‐baseline.] Cognitive Flexibility, measured using the Alternatives subscale from the Cognitive Flexibility Index.[Baseline, 3 months post‐baseline and 6 months post‐baseline] Depressive symptoms, measured using Beck's Depression Inventory[Baseline, 3 months post baseline, and 6 months post‐baseline] Fruit and vegetable serves/day, measured using the online Australian Eating Survey[Baseline, 3 months post‐baseline, and 6 months post‐baseline.] HDL‐Cholesterol (mmol/l), obtained from a fasting finger prick blood sample analysed using a CardioChek analyser and lipid panel test strips. ; ] Masculine depressive symptoms, measured using the Male Depression Risk Scale (MDRS).[Baseline, 3 months post baseline, and 6 months post‐baseline] Mindful Attention, measured using the Mindful Attention Awareness Scale[Baseline, 3 months post‐baseline and 6 months post‐baseline] Perceived global physical self worth, measured using the Global Physical subscale of the Physical Self Perception Profile ‐ short form.[Baseline, 3 months post‐baseline, and 6 months post‐baseline] Perceived physical strength, measured using the Strength subscale of the Physical Self Perception Profile ‐ short form.[Baseline, 3 months post‐baseline, and 6 months post‐baseline.] Resting pulse, measured with the Pulsecor Cardioscope II[Baseline, 3 months post‐baseline and 6 months post‐baseline] Risky alcohol intake, measured using the Alcohol Use Disorders Identification Test (AUDIT) [Baseline, 3 months post‐baseline, and 6 months post‐baseline.] Sleep quality, measured with the Global Pittsburgh Sleep Quality Index (PSQI) score.[Baseline, 3 months post‐baseline, and 6 months post‐baseline.] Total cholesterol (mmol/l), obtained from a fasting finger prick blood sample analysed using a CardioChek analyser and lipid panel test strips.[Baseline, 3 months post‐baseline, and 6 months post‐baseline.] Total cholesterol/HDL‐C ratio, obtained from a fasting finger prick blood sample analysed using a CardioChek analyser and lipid panel test strips.[Baseline, 3 months post‐baseline, and 6 months post‐baseline.
Epistemonikos ID: 6b3b87a3d7ce86699f3a02d7268fb10025970df9
First added on: Aug 24, 2024