Simple Changes Weight Loss Intervention

Study Overview
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Brief Summary
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The investigators examined feasibility and acceptability of a non-restrictive diet focused on increasing dietary fiber and lean protein for weight loss. Fifteen obese adults enrolled in a 12-week assessment which included 6 bi-weekly individual dietary counseling sessions to attain a daily goal of higher fiber (>35 g/day) and lean protein (0.8 g per kilogram/day of individual's ideal body weight).

Detailed Description
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Participants were instructed to increase both their dietary fiber intake to 35 g/day and protein intake to 0.8 g per kilogram/day of their ideal body weight. Loss of 5% of their body weight are considered to achieve the weight-loss goal. The intervention included 6 bi-weekly, 30-minute individual dietary counseling sessions over 12-weeks. Behavioral strategies including self-monitoring, problem solving, goal setting, stimulus control, food substitution, and relapse prevention were taught to assist participants in meeting their fiber and protein goals.

Official Title
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Simple Changes Weight Loss Intervention

Conditions
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Overweight

Intervention / Treatment
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* Behavioral: Dietary Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: interested in losing weight and have a body mass index (BMI) 30-45 kg/m2; ages 21 to 70; able to provide informed consent; physician's approval of his/her patients to participate; non-smoker (given nicotine's effect on weight suppression, on HDL, and smoking cessation's effect on weight Exclusion Criteria: clinically diagnosed diabetes, or an HbA1c ≥ 6.5%; an acute coronary event within the previous 6 months; pregnant or lactating; plans to move out of the area within the 12-week study period; diagnosis of a medical condition that precludes adherence to study dietary recommendations (e.g., inflammatory bowel disease, active diverticulitis, renal disease); following a low-carbohydrate, high-fat dietary regimen such as the Atkins' Diet or participating in a weight loss program; previously had bariatric surgery; currently using weight loss medication; diagnosis of an eating disorder (anorexia nervosa, bulimia nervosa or binge eating); unable to provide consent.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: fiber & protein<br>A single dietary change condition that focuses exclusively on increasing fiber and protein. | Behavioral: Dietary Intervention<br>* Participants were instructed to increase both their dietary fiber intake to 35 g/day and protein intake to 0.8 g per kilogram/day of their ideal body weight. Patients in both conditions will receive intensive dietary instruction for 6 weeks, followed by a 6 weeks maintenance phase. Participants received dietary instructions via individual and group sessions led by registered dietitians.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | kg | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total energy | kcal/day | 12 weeks | 
| Fiber | g/day | 12 weeks | 
| Protein | g/day | 12 weeks | 
| Saturated fat | percent of calories | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fiber, lean protein, loss weight