The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior
Condition: Fasting
Study type: Interventional

Summary: 
      The goal of this randomized controlled trial is to to determine the effects of
      time-restricted feeding intervention on body weight, body composition, biochemical parameters
      and eating behaviors in overweight female individuals.

      The main questions it aims to answer are:

        1. Does time-restricted feeding intervention reduce daily energy intake?

        2. Does time-restricted dietary intervention result in body weight and body fat loss?

        3. Does time-limited nutritional intervention lead to improvements in biochemical
           parameters?

        4. Does time-restricted feeding intervention improve eating behavior and eating awareness?

        5. Does time-restricted feeding intervention adversely affect diet quality?

      The participants in the intervention group will receive a time restricted feeding
      intervention (first meal at 10:00, last meal at 18:00) for 6 weeks. Meals of the participants
      are planned as 8 hours of eating and 16 hours of fasting.

      Participants in the control group will not receive any dietary intervention.
    

Detailed description: 
      Following the ethics committee approval, the study will be carried out with the participants
      who applied to the Famagusta State Hospital Internal Medicine Polyclinic, Specialist Umut
      Hakligil.

      In order to start the study, TR Ministry of Health Nicosia Dr. Necessary permissions were
      obtained from the Ethics Committee of Burhan Nalbantoğlu State Hospital.

      The study is planned to be conducted with 40 female participants, who were not diagnosed with
      any disease by the physician, aged 19-65, slightly obese, with a BMI of 24.9-29.9 kg/m².

      Before being included in the research, participants will be informed about the purpose of the
      research and the applications to be made during the research.

      This information was supported with the valid consent form.

      Data Collection Tool: A questionnaire form developed in line with the research purpose was
      used as a data collection tool in the research.

      While collecting data on the individuals participating in the research, the "face-to-face
      interview method" (mask and distance due to the covid-19 pandemic) by taking necessary
      precautions such as rules of thumb) will be applied.

      Beginning of the Study:

      Participants who meet the study criteria and agree to participate in the study will be
      randomly assigned to the control group or intervention group.

        1. Control group protocol; participants randomized to the control group will not receive
           any dietary intervention. In this process, how all participants should be asked before
           starting the study.

           If they are fed, they will be asked to continue in the same way and to maintain their
           physical activity level.

        2. Intervention group protocol; participants randomized to the intervention group will
           receive a time-restricted feeding intervention for 6 weeks without energy restriction
           (adlibitum). Meals of the participants will be planned as 8 hours of eating and 16 hours
           of fasting.

      Meal timing will be set as follows:

        -  First meal at 10:00,

        -  Last meal at 18:00 in the evening

      Participants will be asked not to consume anything other than non-calorie drinks (water, only
      soda, unsweetened herbal teas, etc.) between 18:00 in the evening and 10:00 in the morning.
    

Intervention name(s): Time restricted feeding
Intervention type(s): Behavioral
Intervention description(s): In the time-restricted nutrition intervention, the first meal is scheduled at 10:00 and the last meal at 18:00 (ad libitum). Eating for 8 hours and fasting for 16 hours are targeted.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other