Doctor referral of overweight people to low energy treatment: the DROPLET trial

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2015
INTERVENTION: Participants are allocated to one of two groups: 1. GP referral to a low energy total diet replacement programme 2. Standard care for weight management offered by primary care providers CONDITION: Obesity in adults ; Nutritional, Metabolic, Endocrine ; Obesity due to excess calories PRIMARY OUTCOME: Change in mean body weight from baseline to 12 months. SECONDARY OUTCOME: Secondary outcome measures as of 15/12/2016:; 1. Change in mean weight between baseline, 3 and 6 months; 2. Proportion of participants achieveing 5 and 10% weight loss at 12 months; 2. Change in mean fat mass between baseline and 12 months; 3. Change in mean low‐density lipoprotein (LDL) cholesterol between baseline and 12 months; 4. Change in mean HbA1c between baseline and 12 months; 5. Change in mean systolic and diastolic blood pressure between baseline and 12 months; ; Original secondary outcome measures:; 1. Change in mean weight between baseline, 12 and 26 weeks.; 2. Change in mean fat mass between baseline and 12, 26 and 52 weeks.; 3. Change in mean low‐density lipoprotein (LDL) cholesterol between baseline and 52 weeks; 4. Change in mean HOMA IR (insulin resistance) between baseline and 52 weeks; 5. Change in mean systolic and diastolic blood pressure between baseline and 12 weeks, 26 weeks and 52 weeks.; 6. Change in the SF‐12 physical functioning scale between baseline and 52 weeks INCLUSION CRITERIA: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, 18 years and older. 3. Body Mass Index =30 kg/m2 4. Likely to benefit from weight loss in the GP’s opinion
Epistemonikos ID: 7e8b6694837b467c1de78551c7b715e647e2059d
First added on: Aug 23, 2024