search
Back to results

Weight Loss in Adults Over 50 With Obesity

Primary Purpose

Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Protein Diet
Resistance Training
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring weight loss, dietary protein, exercise training, fat free mass

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High Protein Diet

Resistance Training

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recruitment and Retention Rates
Rates of study recruitment and retention will be tracked to determine clinical trial feasibility.
Class Attendance
Class Attendance will be tracked to determine clinical trial feasibility.
1st Stage Treatment Credibility
Perceived credibility of 1st stage interventions will be measured at baseline with the Credibility/Expectancy Questionnaire.
2nd Stage Treatment Credibility
Perceived credibility of 2nd stage interventions will be measured in non-responders to 1st stage interventions at week 8 with the Credibility/Expectancy Questionnaire.
1st Stage Intervention Preference
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.
2nd Stage Intervention Preference
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

Body Weight
Changes from baseline body weight will be measured at weeks 8, 16, and 52.
Fat mass
Changes from baseline fat mass will be measured at weeks 8, 16, and 52.
Fat free mass
Changes from baseline fat free mass will be measured at weeks 8, 16, and 52.

Full Information

First Posted
July 5, 2019
Last Updated
July 12, 2023
Sponsor
University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT04014296
Brief Title
Weight Loss in Adults Over 50 With Obesity
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
October 7, 2024 (Anticipated)
Study Completion Date
October 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
weight loss, dietary protein, exercise training, fat free mass

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Protein Diet
Arm Type
Experimental
Arm Description
Enrollment in State of Slim (SOS) weight loss program with a high protein diet.
Arm Title
Resistance Training
Arm Type
Experimental
Arm Description
Enrollment in State of Slim (SOS) weight loss program with resistance training counseling sessions.
Intervention Type
Behavioral
Intervention Name(s)
High Protein Diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resistance Training
Intervention Description
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 Outcome Measure Information:
Title
Recruitment and Retention Rates
Description
Rates of study recruitment and retention will be tracked to determine clinical trial feasibility.
Time Frame
Baseline through week 52.
Title
Class Attendance
Description
Class Attendance will be tracked to determine clinical trial feasibility.
Time Frame
Baseline through week 52.
Title
1st Stage Treatment Credibility
Description
Perceived credibility of 1st stage interventions will be measured at baseline with the Credibility/Expectancy Questionnaire.
Time Frame
Baseline.
Title
2nd Stage Treatment Credibility
Description
Perceived credibility of 2nd stage interventions will be measured in non-responders to 1st stage interventions at week 8 with the Credibility/Expectancy Questionnaire.
Time Frame
Week 8.
Title
1st Stage Intervention Preference
Description
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.
Time Frame
Baseline
Title
2nd Stage Intervention Preference
Description
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.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Body Weight
Description
Changes from baseline body weight will be measured at weeks 8, 16, and 52.
Time Frame
Baseline, Weeks 8, 16, and 52
Title
Fat mass
Description
Changes from baseline fat mass will be measured at weeks 8, 16, and 52.
Time Frame
Baseline, Weeks 8, 16, and 52
Title
Fat free mass
Description
Changes from baseline fat free mass will be measured at weeks 8, 16, and 52.
Time Frame
Baseline, Weeks 8, 16, and 52
Other Pre-specified Outcome Measures:
Title
Change in glucose
Description
Serum glucose will be measured in a fasted state and after a glucose load [mg/dL]
Time Frame
Baseline to Weeks 8, 16, and 52
Title
Change in insulin
Description
Serum insulin will be measured in a fasted state and after a glucose load, measured in micro-units/milliliter [uU/mL]
Time Frame
Baseline to Weeks 8, 16, and 52
Title
Changes in lipids
Description
Fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides
Time Frame
Baseline to Weeks 8, 16, and 52
Title
Changes in disposition index
Description
Derived from Oral Glucose Tolerance Test (OGTT) using 0 minute and 30 minute time-points.
Time Frame
Baseline to Weeks 8, 16, and 52
Title
Changes in aerobic fitness
Description
6-Minute Walk test for ambulatory participants OR 6-Minute Push test for wheelchair users.
Time Frame
Baseline to Weeks 8, 16, and 52
Title
Changes in physical activity
Description
7-day accelerometry
Time Frame
Baseline to Weeks 8, 16, and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drew Sayer, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3360
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Weight Loss in Adults Over 50 With Obesity

We'll reach out to this number within 24 hrs