Knowledge-based Dietary Weight Management.

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 (iDip) for Weight Loss and Maintenance.

Conditions
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Weight Loss, Dietary Modifications, Obesity, Sustainability

Intervention / Treatment
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* Other: Weight management


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: age 18-64 years; body mass index (BMI) >28 kg/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 one and a half years. fluent in reading and writing English. Exclusion criteria: age <18 or >64 years; body mass index of <28 kg/m2; currently pregnant; currently lactating; self-reported with the 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 food frequency questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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
Interventional Model Description: Before and after study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Eligible participants will be in an intervention group led by a registered dietitian | Other: Weight management<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.<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 | Change from baseline body weight at 6 months | 
| Body weight | Body weight in kilograms | Change from baseline body weight at 12 months | 
| Body weight | Body weight in kilograms | Change from baseline body weight at 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference | Waist circumference in centimeters | Change from baseline waist circumference at 12 months | 
| Hip circumference | Hip circumference in centimeters | Change from baseline hip circumference at 12 months | 
| Protein intake | Protein intake in grams and caloric intake will be combined to report density in g/100kcal | Change from baseline protein intake at 6 months | 
| Protein intake | Protein intake in grams and caloric intake will be combined to report density in g/100kcal | Change from baseline protein intake at 12 months | 
| Fiber intake | Fiber intake in grams and caloric intake will be combined to report density in g/100kcal | Change from baseline fiber intake at 6 months | 
| Fiber intake | Fiber intake in grams and caloric intake will be combined to report density in g/100kcal | Change from baseline fiber intake at 12 months |