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Simple Changes Weight Loss Intervention

Simple Changes Weight Loss Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02968615
Enrollment
15
Registered
2016-11-18
Start date
2015-05-31
Completion date
2016-04-30
Last updated
2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Keywords

fiber, lean protein, loss weight

Brief summary

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

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.

Interventions

BEHAVIORALDietary Intervention

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.

Sponsors

University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

1. interested in losing weight and have a body mass index (BMI) 30-45 kg/m2; 2. ages 21 to 70; 3. able to provide informed consent; 4. physician's approval of his/her patients to participate; 5. non-smoker (given nicotine's effect on weight suppression, on HDL, and smoking cessation's effect on weight

Exclusion criteria

1. clinically diagnosed diabetes, or an HbA1c ≥ 6.5%; 2. an acute coronary event within the previous 6 months; 3. pregnant or lactating; 4. plans to move out of the area within the 12-week study period; 5. diagnosis of a medical condition that precludes adherence to study dietary recommendations (e.g., inflammatory bowel disease, active diverticulitis, renal disease); 6. following a low-carbohydrate, high-fat dietary regimen such as the Atkins' Diet or participating in a weight loss program; 7. previously had bariatric surgery; 8. currently using weight loss medication; 9. diagnosis of an eating disorder (anorexia nervosa, bulimia nervosa or binge eating); 10. unable to provide consent.

Design outcomes

Primary

MeasureTime frameDescription
Weight loss12 weekskg

Secondary

MeasureTime frameDescription
Total energy12 weekskcal/day
Fiber12 weeksg/day
Protein12 weeksg/day
Saturated fat12 weekspercent of calories

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026