ObesityNCT02938897
Telenutrition Weight Loss Study for Men
A study testing Registered Dietitian Nutritionist (RDN) Support, Diet-related educational materials and Self-monitoring tools in people with Obesity and Weight Loss, run by West Virginia University.
Trial summary
This study is a 12-week pilot randomized controlled trial to test the feasibility and effectiveness of a home telenutrition weight loss program in men in West Virginia. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss, Men
- What is being tested?
- Registered Dietitian Nutritionist (RDN) Support, Diet-related educational materials and Self-monitoring tools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2016
- 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 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40-70 year old man
- Body mass index ≥ 30
- Living with spouse or companion
- At least one of the following: hypertension, diabetes, pre-diabetes, hypercholesterolemia or hypertriglyceridemia
- A home computer with high-speed internet access
- A telephone for health coach phone calls
Who cannot join
- Cancer (except skin or prostate), celiac disease, bacterial or viral infections, renal or liver disease (except non-alcoholic fatty liver disease), or condition that prevents fruits and vegetable consumption
- Major surgery or health event (e.g., stroke, heart attack) in the past six months
- Taking insulin, anti-obesity medications, steroids (e.g., Prednisone), or warfarin (Coumadin)
- Pacemaker or defibrillator
- Currently on a weight loss diet or lost > 10 pounds in past six months
- Consume more than two alcoholic beverages daily
About this study
Official title: A Pilot Randomized Controlled Trial of a Home Telenutrition Weight Loss Program in Men
This study is a 12-week pilot randomized controlled trial to test the feasibility and effectiveness of a home telenutrition weight loss program in men in West Virginia.
Read the detailed description
This study is a 12-week pilot randomized controlled trial of a home telenutrition weight loss program for men with obesity and at least one additional risk factor for cardiovascular disease. The primary aims are to:
- To assess the feasibility and acceptability of the male-targeted telenutrition weight loss program in terms of recruitment, retention and satisfaction and
- To evaluate the effectiveness of the telenutrition program compared to usual care (informational only) with regard to primary and secondary outcome measures at 12 weeks. We hypothesized that men receiving virtual and telephonic support from a registered dietitian nutritionist would have greater weight loss and greater improvements in diet quality than men who were only provided educational materials.
- Conditions
- Obesity, Weight Loss, Men
- Being tested
- Registered Dietitian Nutritionist (RDN) Support, Diet-related educational materials, Self-monitoring tools
- Keywords
- Telehealth, Weight loss, Diet quality, Behavioral counseling
- Medical subject headings
- Obesity, Weight Loss, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registered Dietitian Nutritionist (RDN) SupportBehavioural
RDN provided individualized medical nutrition therapy via videoconference at weeks 1, 5, and 9 and telephonic nutrition coaching support at weeks 2-4, 6-8, and 10-12.
Diet-related educational materialsBehavioural
Individualized caloric recommendations (500-750 kcal reduction) were made and food-based educational materials emphasizing general healthful eating patterns and increased intakes of nutrient-rich foods were provided.
Self-monitoring toolsBehavioural
Self-monitoring tools including: weekly weight log, fruit and vegetable tracker, and a SMART (specific, measurable, achievable, relevant, and time bound) goal planner were provided.
| Study group | Role | What they receive |
|---|---|---|
| Telenutrition Intervention | Experimental | Participants receive diet-related educational materials and self-monitoring tools PLUS registered dietitian nutritionist support. Receives: Behavioral: Registered Dietitian Nutritionist (RDN) Support; Behavioral: Diet-related educational materials; Behavioral: Self-monitoring tools |
| Enhanced Usual Care Control | Active comparator | Participants receive diet-related educational materials and self-monitoring tools. Receives: Behavioral: Diet-related educational materials; Behavioral: Self-monitoring tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Measured: Baseline to 12 weeks
Secondary outcomes (7)
Change in Waist Circumference
Measured: Baseline to 6 and 12 weeks
Change in Caloric Intake
Measured: Baseline to 6 and 12 Weeks
Change in Diet and Diet Quality
4-day food records, Healthy Eating Index-2010.
Measured: Baseline to 6 and 12 Weeks
Change in Body Composition
Bioelectrical impedance analysis
Measured: Baseline to 6 and 12 Weeks
Health Related Quality of Life
HRQOL-4
Measured: Baseline and 12 Weeks
Program Satisfaction
Questionnaire
Measured: 6 and 12 Weeks
Program Usefulness
Questionnaire
Measured: 6 and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Ventura-Marra, West Virginia University
- Investigators
- Melissa D Ventura-Marra, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938897
- Sponsor's protocol ID
- 1501549080
- Status last verified
- Oct 2016
- First submitted
- 25 Sep 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will only be reported in aggregate.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of a Home Telenutrition Weight Loss Program in Men
- ClinicalTrials.gov ID
- NCT02938897
- Acronym / sponsor ID
- 1501549080
- Conditions
- Obesity, Weight Loss, Men
- Keywords
- Telehealth, Weight loss, Diet quality, Behavioral counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 19 Oct 2016 (estimated)
- 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.
This study is a 12-week pilot randomized controlled trial to test the feasibility and effectiveness of a home telenutrition weight loss program in men in West Virginia.
Detailed description
This study is a 12-week pilot randomized controlled trial of a home telenutrition weight loss program for men with obesity and at least one additional risk factor for cardiovascular disease. The primary aims are to:
- To assess the feasibility and acceptability of the male-targeted telenutrition weight loss program in terms of recruitment, retention and satisfaction and
- To evaluate the effectiveness of the telenutrition program compared to usual care (informational only) with regard to primary and secondary outcome measures at 12 weeks. We hypothesized that men receiving virtual and telephonic support from a registered dietitian nutritionist would have greater weight loss and greater improvements in diet quality than men who were only provided educational materials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telenutrition Intervention | Experimental | Behavioral: Registered Dietitian Nutritionist (RDN) Support, Behavioral: Diet-related educational materials, Behavioral: Self-monitoring toolsParticipants receive diet-related educational materials and self-monitoring tools PLUS registered dietitian nutritionist support. |
| Enhanced Usual Care Control | Active comparator | Behavioral: Diet-related educational materials, Behavioral: Self-monitoring toolsParticipants receive diet-related educational materials and self-monitoring tools. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 40-70 year old man
- Body mass index ≥ 30
- Living with spouse or companion
- At least one of the following: hypertension, diabetes, pre-diabetes, hypercholesterolemia or hypertriglyceridemia
- A home computer with high-speed internet access
Key exclusion criteria (6 listed)
- Cancer (except skin or prostate), celiac disease, bacterial or viral infections, renal or liver disease (except non-alcoholic fatty liver disease), or condition that prevents fruits and vegetable consumption
- Major surgery or health event (e.g., stroke, heart attack) in the past six months
- Taking insulin, anti-obesity medications, steroids (e.g., Prednisone), or warfarin (Coumadin)
- Pacemaker or defibrillator
- Currently on a weight loss diet or lost > 10 pounds in past six months
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 |
|---|---|---|
| Registered Dietitian Nutritionist (RDN) SupportRDN provided individualized medical nutrition therapy via videoconference at weeks 1, 5, and 9 and telephonic nutrition coaching support at weeks 2-4, 6-8, and 10-12. | Behavioural | Telenutrition Intervention |
| Diet-related educational materialsIndividualized caloric recommendations (500-750 kcal reduction) were made and food-based educational materials emphasizing general healthful eating patterns and increased intakes of nutrient-rich foods were provided. | Behavioural | Enhanced Usual Care Control, Telenutrition Intervention |
| Self-monitoring toolsSelf-monitoring tools including: weekly weight log, fruit and vegetable tracker, and a SMART (specific, measurable, achievable, relevant, and time bound) goal planner were provided. | Behavioural | Enhanced Usual Care Control, Telenutrition Intervention |
Primary outcome
Change in Weight
Time frame: Baseline to 12 weeks
7 secondary outcomes
Change in Waist Circumference
Time frame: Baseline to 6 and 12 weeks
Change in Caloric Intake
Time frame: Baseline to 6 and 12 Weeks
Change in Diet and Diet Quality
Time frame: Baseline to 6 and 12 Weeks
Change in Body Composition
Time frame: Baseline to 6 and 12 Weeks
Health Related Quality of Life
Time frame: Baseline and 12 Weeks
Program Satisfaction
Time frame: 6 and 12 Weeks
Program Usefulness
Time frame: 6 and 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 19 Oct 2016.
- Individual participant dataSharing planned: No. Data will only be reported in aggregate.
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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.
Melissa D Ventura-Marra, PhD principal investigator
West Virginia University
Questions about this trial
What is this clinical trial studying?
A study testing Registered Dietitian Nutritionist (RDN) Support, Diet-related educational materials and Self-monitoring tools in people with Obesity and Weight Loss, run by West Virginia University.
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 6 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 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Weight (time frame: Baseline to 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 19 Oct 2016.