The effect of addressing sleep in a weight loss program on diet, exercise and weight loss in Lebanese university students: a pilot randomized controlled trial
Overweight and obesity
This study will use a two-arm, parallel-group design to investigate whether improving sleep duration and quality, in parallel with a weight-loss program, leads to spillover effects on adherence and weight-loss outcomes. Participants will be randomly allocated in a 1:1 ratio to either (1) usual care (diet + exercise) or (2) sleep spillover group (usual care plus a sleep education and health identity stimulation). We aim to recruit approximately 12 participants per arm. Randomization will be done using a sealed-envelope method. An independent researcher who has no other role in intervention or assessment will prepare group assignments in advance according to a random sequence generated. Each assignment will be placed in an opaque, sealed, and sequentially numbered envelope. Upon enrollment, the study coordinator will open the next envelope in sequence to reveal group allocation. Participants will be followed for 6 months, with monthly visits conducted by a licensed nutritionist. Group 1: Usual Care (diet + exercise) Participants in this group will receive an individualized weight loss diet and exercise program without any sleep-related education or identity stimulation components. Each participant will receive: 1. An individualized dietary program aiming at losing 1-2 pounds per week (removing 500-1000 Calories per day), accompanied by educational materials to support adherence. 2. Individualized physical activity recommendations aiming to reach at least 150 min/week. 3. Guidance on cognitive-behavioral strategies to support healthy habits, including the consumption of regular meals without skipping any of the 3 main meals, eating at consistent time, avoiding excessive snacking especially evening snacking, avoiding sweet snacks and avoiding eating late at night). Group 2: Sleep spillover group + Usual Care for weight loss Participants in this group will receive a weight loss program similar to Group 1 including dietary, physical activity, and behavior modificatio
1. Participants should be overweight or obese (BMI≥ 25 kg/m²) 2. Participants should have a short sleep duration (< 7 hours per night) and/or a poor sleep quality (PSQI score > 5) (The validated Arabic version of the PSQI will be used to assess eligibility) 3. Participants should be healthy, not suffering from any metabolic or other chronic diseases
1. Students diagnosed or being treated for insomnia, obstructive sleep apnea (OSA), other sleep disorders or any other medical condition that may affect negatively the weight loss like endocrine problems (hypothyroidism…) 2. Students having any medical contraindication to weight loss 3. Students taking any medication known to affect body weight 4. Students taking any medication known to affect sleep 5. Students who are already engaged in another weight loss program or who were recently losing weight (> 5% in the past 3 months) 6. Pregnant/planning to become pregnant in the next 6 months, or breastfeeding 7. Students who smoke waterpipe as this has been found in a previous study to affect weight loss