Individualized Diet Improvement Program for Weight Loss and Maintenance, Cohort 2

Study Overview
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Brief Summary
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This research is to develop a weight loss and weight maintenance program through dietary modifications for adults with obesity. Although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management. Safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.

Official Title
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Individualized Diet Improvement Program for Weight Loss and Maintenance

Conditions
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Obesity, Overweight, Weight Loss, Diet Habit

Intervention / Treatment
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* Behavioral: Weight Management Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body mass index in the overweight or obese range (BMI) >28 kg/m2 (if Asian, BMI >25kg/m2); not currently pregnant or lactating; have Wi-Fi at home, a working email, and an iPhone or Android smartphone; no self-reported severe metabolic, cardiovascular or musculoskeletal disease; not using insulin injection; able to attend the 22 (1 hour) diet improvement sessions; willing to lose 20 lb. or more for 6 months and maintain a healthy weight for one year; keep weighing their weight for two years; fluent in reading and writing English. Exclusion Criteria: age <18 or >70 years; body mass index of <28 kg/m2 (if Asian, BMI <25kg/m2); currently pregnant; currently lactating; self-reported with severe metabolic, cardiovascular, or musculoskeletal disease; use insulin injection; not able to attend the 22 (1 hour) diet improvement sessions for 1 year; failed to set up a Wi-Fi scale; failed to submit a FFQ.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Management Intervention<br>During a 12-month period, participants will attend a total of 22 diet improvement sessions, each of which will last approximately 1 hour. Twelve sessions will be held in the first 5 months and will be focused on safe and efficient weight loss. The participants will learn to create a personalized weight loss diet from their kitchen based on their diet practice and food preference. The next 10 sessions will be held in the last 7 months and will be focused on weight maintenance and healthy eating. The participants will build skills to select foods and create meals that prevent them from overeating. Participants will be followed by daily self-weighing for 1 year after intervention. | Behavioral: Weight Management Intervention<br>* Participants attend group and individual dietary education sessions. Participants create a diet plan that satisfies their needs. Participants aim to lose 1 pound weekly until a BMI of 25 is reached. Participants are evaluated through daily self-weighing, dietary records, and food frequency questionnaires.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Body weight in kilograms measured on a standard scale (Withings, US) | Change from baseline (0 month) to 6 month, 12 month, 18 month, and 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference | Waist circumference in centimeters measured using a standard measuring tape | Change from baseline (0 month) to 6 month, 12 month, 24 month | 
| Hip circumference | Hip circumference in centimeters measured using a standard measuring tape | Change from baseline (0 month) to 6 month, 12 month, 24 month | 
| Body composition | Body fat measured using InBody 270 | Change from baseline (0 month) to 6 month, 12 month, 24 month | 
| Body composition | muscle mass measured using InBody 270 | Change from baseline (0 month) to 6 month, 12 month, 24 month | 
| Protein intake | Protein intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ) | Change from baseline (0 month) to 12 month | 
| Protein intake | Protein intake in grams and grams/100 kilo-calories using a 24-hour dietary record | Periodically from baseline (0 month) to 12 month | 
| Fiber intake | Fiber intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ) | Change from baseline (0 month) to 12 month | 
| Fiber intake | Fiber intake in grams and grams/100 kilo-calories using a 24-hour dietary record | Periodically from baseline (0 month) to 12 month |