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CompletedNCT02968615Updated Nov 18, 2016

Simple Changes Weight Loss Intervention

An interventional study of Dietary Intervention in Overweight, sponsored by University of Massachusetts, Worcester. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-18.

Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
21 Years to 70 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Overweight

Keywords

  • fiber
  • lean protein
  • loss weight
03

In context

Overweight

3,771 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's enrollment of 15 is below the median of 73 across 3,263 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

University of Massachusetts, Worcester is the lead sponsor of 290 studies on the registry; 51 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    fiber & protein

    A single dietary change condition that focuses exclusively on increasing fiber and protein.

    Behavioral: Dietary Intervention

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.

06

What researchers measure

Primary outcomes

  1. Weight loss

    kg

    Time frame: 12 weeks

Secondary outcomes

  1. Total energy

    kcal/day

    Time frame: 12 weeks

  2. Fiber

    g/day

    Time frame: 12 weeks

  3. Protein

    g/day

    Time frame: 12 weeks

  4. Saturated fat

    percent of calories

    Time frame: 12 weeks

07

Study locations

1 site
  • University of Massachusetts Medical School
    Worcester, Massachusetts 01655, United States
08

References and documents

Individual participant data

Plan to share: Undecided — Please contact with PI

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02968615
Responsible party
Yunsheng Ma (Associate professor, University of Massachusetts, Worcester) — Principal investigator
First posted
Nov 18, 2016
Start date
May 2015
Primary completion
Jun 2015
Completion
Apr 2016
Last update
Nov 18, 2016

Study contacts

Yunsheng Ma, MD, Ph.D.
principal investigator · University of Massachusetts, Worcester

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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