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OpenTrials
Completed

NCT Number: NCT04014296

Weight Loss in Adults Over 50 with Obesity

The purpose of this study is to examine the separate and combined effects of a high-protein (HP) diet and resistance training (RT) on body composition and potential biological moderators of body weight in women and men >50y. All participants will receive dietary physical activity guidance through our group-based weight loss program, State of Slim (SOS). The SOS program will be delivered via the Zoom videoconferencing platform. These participants will be randomized to receive either a counseling-based HP diet plan or RT plan. Body composition assessments at 8 wk will identify responders and non-responders; the latter will be re-randomized to "augment" (HP: add protein supplements; RT: supervise RT) or "combine" (HP with protein supplements + supervised RT).

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3360, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or Female
  • Age ≥50 years
  • Post-menopausal if Female
  • BMI of 30-50 kg/m2 for ambulatory participants (less than or equal to 350 lbs.)
  • BMI of 25-50 kg/m2 for wheelchair users (less than or equal to 350 lbs.)
  • Ambulatory with or without a walking device or use of a manual wheelchair for mobility.

Exclusion criteria

  • Untreated hyper or hypothyroidism.
  • Cancer (except basal cell).
  • Gastrointestinal disorders affecting food intake.
  • <3 months of stable use of medications that affect metabolism, body weight, energy expenditure or appetite.
  • Current eating disorder (e.g., binge eating disorder, anorexia, or bulimia).
  • Any medical condition for which following a HP diet and/or 70 minutes of exercise daily would be inadvisable.
  • Uses a powered wheelchair for mobility.
  • Has a pacemaker or any other life-sustaining medical implant.

Treatment and study plan

High Protein Diet

Behavioral

16 week group-based weight loss program with high protein diet. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%. Because this protocol uses a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed after 8 weeks. Non-responders will be randomized to either combine the HP diet with supervised resistance training counseling (2 days per week) or add a protein supplement.

Resistance training

Behavioral

16 week weight loss program with normal protein diet and resistance training counseling. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:20%:26%. Because this protocol uses a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed after 8 weeks. Non-responders will be randomized to either combine resistance training with HP/protein supplement or add supervised sessions with a personal trainer (2 days per week) to the resistance training regimen.

Primary outcomes

  1. Recruitment and Retention Rates

    Time frame: Baseline through week 52.

    Rates of study recruitment and retention will be tracked to determine clinical trial feasibility.

  2. Class Attendance

    Time frame: Baseline through week 52.

    Class Attendance will be tracked to determine clinical trial feasibility.

  3. 1st Stage Treatment Credibility

    Time frame: Baseline.

    Perceived credibility of 1st stage interventions will be measured at baseline with the Credibility/Expectancy Questionnaire.

  4. 2nd Stage Treatment Credibility

    Time frame: Week 8.

    Perceived credibility of 2nd stage interventions will be measured in non-responders to 1st stage interventions at week 8 with the Credibility/Expectancy Questionnaire.

  5. 1st Stage Intervention Preference

    Time frame: Baseline

    Participant preferences for 1st stage interventions will be measured at baseline by answering a 5-point Likert question with '1' and '5' representing a strong preference for either intervention and '3' representing no intervention preference.

  6. 2nd Stage Intervention Preference

    Time frame: Week 8

    Participant preferences for 2nd stage interventions will be measured at week 8 by answering a 5-point Likert question with '1' and '5' representing a strong preference for either intervention and '3' representing no intervention preference.

Secondary outcomes

  1. Body Weight

    Time frame: Baseline, Weeks 8, 16, and 52

    Changes from baseline body weight will be measured at weeks 8, 16, and 52.

  2. Fat mass

    Time frame: Baseline, Weeks 8, 16, and 52

    Changes from baseline fat mass will be measured at weeks 8, 16, and 52.

  3. Fat free mass

    Time frame: Baseline, Weeks 8, 16, and 52

    Changes from baseline fat free mass will be measured at weeks 8, 16, and 52.

Other outcomes

  1. Change in glucose

    Time frame: Baseline to Weeks 8, 16, and 52

    Serum glucose will be measured in a fasted state and after a glucose load [mg/dL]

  2. Change in insulin

    Time frame: Baseline to Weeks 8, 16, and 52

    Serum insulin will be measured in a fasted state and after a glucose load, measured in micro-units/milliliter [uU/mL]

  3. Changes in lipids

    Time frame: Baseline to Weeks 8, 16, and 52

    Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides

  4. Changes in disposition index

    Time frame: Baseline to Weeks 8, 16, and 52

    Derived from Oral Glucose Tolerance Test (OGTT) using 0 minute and 30 minute time-points.

  5. Changes in aerobic fitness

    Time frame: Baseline to Weeks 8, 16, and 52

    6-Minute Walk test for ambulatory participants OR 6-Minute Push test for wheelchair users.

  6. Changes in physical activity

    Time frame: Baseline to Weeks 8, 16, and 52

    7-day accelerometry

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Effects of Dietary Protein Intake and Resistance Training on Retention of Fat Free Mass During Weight Loss in Adults Over 50 with Obesity

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2019
Registry last updated
Oct 21, 2024

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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