Dietary HabitsNCT04660851
Improving Diet Protein Intake in Middle-aged Women
A study testing Coached in people with Dietary Habits, run by Florida Atlantic University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits
- What is being tested?
- Coached
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2019to 24 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Atlantic University
Boca Raton, Florida, 33431
About this study
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.
Read the 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.
- Conditions
- Dietary Habits
- Being tested
- Coached
- Keywords
- Protein intake, coaching, strength
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoachedBehavioural
10-weeks of diet coaching weekly by telephone to improve dietary protein intake
| Study group | Role | What they receive |
|---|---|---|
| Coached | Experimental | 10 weeks of diet coaching Receives: Behavioral: Coached |
| Not-coached | No intervention | No coaching provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in dietary protein intake from baseline
Assessed changes in dietary protein intake from three 24-hour dietary recalls collected at baseline.
Measured: 12 weeks
Secondary outcomes (4)
Changes in muscle mass
Changes in muscle mass from baseline were measured using bioelectrical impedance analysis
Measured: 12 weeks
Changes in upper body muscle strength
Changes in handgrip strength from baseline were measured using hand dynamometer
Measured: 12 weeks
Changes in lower body muscle strength and function
Changes in 5-chair stand times from baseline were assessed
Measured: 12 weeks
Changes in muscle function
Changes in 4 meter gait speed from baseline were assessed
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start26 Jun 2019
- Primary completion24 Jan 2020
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Atlantic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sareen Gropper, PhD, RDN, LDN, Florida Atlantic University
- Investigators
- Sareen S Gropper, PhD, Principal investigator, Professor, College of Nursing, Florida Atlantic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660851
- Sponsor's protocol ID
- 1440147-1
- Status last verified
- Dec 2020
- First submitted
- 16 Oct 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diet Protein Intake in Middle-aged Women
- ClinicalTrials.gov ID
- NCT04660851
- Acronym / sponsor ID
- 1440147-1
- Conditions
- Dietary Habits
- Keywords
- Protein intake, coaching, strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Florida Atlantic UniversityUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coached | Experimental | Behavioral: Coached10 weeks of diet coaching |
| Not-coached | No intervention | –No coaching provided |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coached10-weeks of diet coaching weekly by telephone to improve dietary protein intake | Behavioural | Coached |
Primary outcome
Changes in dietary protein intake from baseline
Time frame: 12 weeks
Assessed changes in dietary protein intake from three 24-hour dietary recalls collected at baseline.
4 secondary outcomes
Changes in muscle mass
Time frame: 12 weeks
Changes in upper body muscle strength
Time frame: 12 weeks
Changes in lower body muscle strength and function
Time frame: 12 weeks
Changes in muscle function
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Individual participant dataSharing planned: No
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Dietary Habits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sareen S Gropper, PhD principal investigator
Professor, College of Nursing, Florida Atlantic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coached in people with Dietary Habits, run by Florida Atlantic University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in dietary protein intake from baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.