Weight Loss in Adults Over 50 With Obesity

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT04014296
Collaborator
(none)
90
1
2
41.9
2.2

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: High Protein Diet
  • Behavioral: Resistance Training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Dietary Protein Intake and Resistance Training on Retention of Fat Free Mass During Weight Loss in Adults Over 50 With Obesity
Actual Study Start Date :
Apr 12, 2021
Anticipated Primary Completion Date :
Oct 7, 2024
Anticipated Study Completion Date :
Oct 7, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: High Protein Diet

Enrollment in State of Slim (SOS) weight loss program with a high protein diet.

Behavioral: High Protein Diet
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.

Experimental: Resistance Training

Enrollment in State of Slim (SOS) weight loss program with resistance training counseling sessions.

Behavioral: Resistance Training
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.

Outcome Measures

Primary Outcome Measures

  1. Recruitment and Retention Rates [Baseline through week 52.]

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

  2. Class Attendance [Baseline through week 52.]

    Class Attendance will be tracked to determine clinical trial feasibility.

  3. 1st Stage Treatment Credibility [Baseline.]

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

  4. 2nd Stage Treatment Credibility [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 [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 [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 Outcome Measures

  1. Body Weight [Baseline, Weeks 8, 16, and 52]

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

  2. Fat mass [Baseline, Weeks 8, 16, and 52]

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

  3. Fat free mass [Baseline, Weeks 8, 16, and 52]

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

Other Outcome Measures

  1. Change in glucose [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 [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 [Baseline to Weeks 8, 16, and 52]

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

  4. Changes in disposition index [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 [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 [Baseline to Weeks 8, 16, and 52]

    7-day accelerometry

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294-3360

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

  • Principal Investigator: Drew Sayer, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Drew Sayer, Primary Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT04014296
Other Study ID Numbers:
  • IRB-300003818
First Posted:
Jul 10, 2019
Last Update Posted:
Feb 23, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Drew Sayer, Primary Investigator, University of Alabama at Birmingham
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2022