Improving Diet Protein Intake in Middle-aged Women | NCT04660851

Studies
Improving Diet Protein Intake in Middle-aged Women

NCT04660851

Sponsor

Florida Atlantic University

Status

Completed

Last Update Posted

Dec 9, 2020Actual

Enrollment

54Actual

Phase

Not Applicable

Conditions

Dietary Habits

Interventions

Coached

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 26, 2019Actual

Primary Completion Date

Jan 24, 2020Actual

Completion Date

Jan 24, 2020Actual

First Submitted Date

Oct 16, 2020

First Submission Date that Met QC Criteria

Dec 7, 2020

First Posted Date

Dec 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2020

Last Update Posted Date

Dec 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study sought to examine the effectiveness of nutrition education with and without diet coaching on dietary protein intake and muscle mass, strength and function among a group of middle-aged women.

Detailed Description

The study sought to examine the effectiveness of nutrition education alone and with 10 weeks of diet coaching on dietary protein intake and muscle mass, strength and function among a group of middle-aged women.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Coached	Experimental	10 weeks of diet coaching	Behavioral: Coached
Not-coached	No Intervention	No coaching provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coached	Behavioral	10-weeks of diet coaching weekly by telephone to improve dietary protein intake	Coached

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in dietary protein intake from baseline	Assessed changes in dietary protein intake from three 24-hour dietary recalls collected at baseline.	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in muscle mass	Changes in muscle mass from baseline were measured using bioelectrical impedance analysis	12 weeks
Changes in upper body muscle strength	Changes in handgrip strength from baseline were measured using hand dynamometer

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

able to understand and respond to questions or instructions in English
working telephone
willingness to consume protein-containing animal products,
willingness to make changes to the diet

Exclusion Criteria:

self-reported information that they have been told by a medical doctor that they have kidney (renal) disease
current or past history of a diagnosed eating disorder
have an internal cardiac pacemaker/defibrillator or other metal-type implant present
vegan dietary practices
refusal to make changes to usual dietary protein intake
usual dietary protein intake greater than 1.2 g per kg body weight

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sareen S Gropper, PhD	Professor, College of Nursing, Florida Atlantic University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Florida Atlantic University		Boca Raton	Florida	33431	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005247	Feeding Behavior

Ancestor Terms

ID	Term
D001522	Behavior, Animal
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided