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OpenTrials
Completed

NCT Number: NCT02968615

Simple Changes Weight Loss Intervention

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).

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary intervention

Behavioral

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.

Primary outcomes

  1. Weight loss

    Time frame: 12 weeks

    kg

Secondary outcomes

  1. Total energy

    Time frame: 12 weeks

    kcal/day

  2. Fiber

    Time frame: 12 weeks

    g/day

  3. Protein

    Time frame: 12 weeks

    g/day

  4. Saturated fat

    Time frame: 12 weeks

    percent of calories

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Nov 18, 2016
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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