Chronic Kidney DiseaseNCT02266823
Diabetes CKD Lifestyle Technology Study
A study testing Social Cognitive Theory in people with Chronic Kidney Disease and Diabetes, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to pilot test an mHealth technology-supported behavioral intervention designed to engage patients with diabetes and concurrent chronic kidney disease (CKD) in multiple behaviors which aim to reduce CKD progression. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Kidney Disease, Diabetes, Obesity
- What is being tested?
- Social Cognitive Theory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 8 Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible for the study, the individual must be 40 years of age or older; have a DRG Code of T2DM, GFR of 15-89 ml/min/1.73m2 and a BMI >30 kg/m2. The participant's physician of record will have verified that his/her patient can safely participant in an intervention study that involves weight loss and a goal of 150 minutes/week of moderate physical activity (comparable to brisk walking).
Who cannot join
- Those with the following characteristics will be excluded by the investigators:
- unable or unwilling to provide informed consent; (2) unable to participate meaningfully in an intervention that involves group sessions (e.g., due to uncorrected hearing impairment, non-English-speaking); (3) unable to read or otherwise use an iPad to monitor dietary intake, physical activity, and weight (e.g., blind, illiterate); (4) unwilling to accept randomization assignment; (5) pregnant, or plans to become pregnant in the next 12 months, less than 3 months postpartum, or nursing or within 6 weeks of having completed nursing; (6) weight loss of > 10% in the past 6 months except for postpartum weight loss; and (7) individuals who are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have no control over their diet).
- will exclude from the study those with underlying diseases which would increase the risk of participating in an intervention involving caloric restriction and physical activity. Such individuals would include those requiring treatment for cancer, exclusive of skin cancer other than melanoma, in the past 2 years; infectious diseases including untreated AIDS and active tuberculosis; uncontrolled hypertension of >190 mmHg SBP or >105 mmHg DBP despite treatment; stroke or TIA in the past 6 months; conditions requiring the use of home oxygen; or other chronic disease or condition likely to limit life span to < 1 year. A recent Institute of Medicine report suggests that reducing dietary sodium below 1,840 mg/day in those with mid- to late-stage heart failure may increase adverse events or mortality. Thus investigators will exclude those with heart failure.
- Because of the dietary requirements of a pregnant woman, and the nature of weight loss and gain with pregnancy, inclusion of pregnant women in the study would confound the study results. Those who become pregnant during the study will be withdrawn from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
Official title: Program to Improve Care in Complex Chronic Disease
The purpose of this study is to pilot test an mHealth technology-supported behavioral intervention designed to engage patients with diabetes and concurrent chronic kidney disease (CKD) in multiple behaviors which aim to reduce CKD progression. Participants will be randomized to the 6-month lifestyle intervention or to a wait-list control. The lifestyle intervention will be modeled after that used in the Diabetes Prevention Program (DPP) and the counseling intervention will be based on SCT, which will be paired with mobile technology-based dietary and physical activity monitoring. The wait-list control will receive 6 months of standard medical care followed by a delayed, but less intensive, 6-month intervention.
Read the detailed description
The purpose of this study is to develop and pilot test a lifestyle intervention in obese individuals with t2dm and concurrent stage 2-4 ckd. The counseling intervention will be based on social cognitive theory and supported by mobile (ipad) self-monitoring. Mobile self-monitoring is featured in the intervention to encourage vigilance to the diet in a manner that is not burdensome, enhance self-efficacy by integrating complex information regarding the ckd dietary regimen with a calorie-restricted diet, and permit real-time monitoring of weight, blood glucose, blood pressure, and self-reported diet and physical activity by the study team.
Specifically, the investigators will develop the methods for and pilot test the ckd lifestyle intervention in stage 2-4 ckd patients and explore the impact of the intervention on: (a) weight and fat mass, (b) blood pressure, (c) physical activity, (d) urinary sodium excretion, (e) serum phosphorus and calcium-phosphorus product, (f) kidney function as measured by serum cystatin-c, and (g) serum lipids. Additionally, we will evaluate the feasibility and acceptability of this intervention in terms of: (h) recruitment and retention, (i) time and cost associated with training ckd patients in technology-based self-monitoring and in delivering the intervention, (j) patterns of self-monitoring adherence over time, and (k) participant satisfaction with the intervention. Finally, we will describe: (l) the extent to which the intervention differentially adversely affects the nutritional health of participants as evidenced by low serum albumin or serum prealbumin; a body mass index (bmi) that falls below 20kg/m2; and subjective assessment of nutritional risk (e.g. Nausea, diarrhea, anorexia).
- Conditions
- Chronic Kidney Disease, Diabetes, Obesity
- Being tested
- Social Cognitive Theory
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Cognitive TheoryBehavioural
Also called SCT
The intervention, which combines behavioral counseling with mobile self-monitoring, will be based on SCT which focuses on the role played by self-referent thought in the maintenance of behavior change. Within SCT, behavior change and maintenance are influenced strongly by the individual's perceived self-efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Lifestyle A. | Active comparator | Lifestyle A will receive an iPad loaded with a self-monitoring program used to support vigilance, reduce the information processing requirements, make readily available the information required to make good self-management decisions, provide real-time feedback, and permit targeted counseling in the context within which lifestyle behaviors occur.
Using Social Cognitive Theory, the study dietitian will counsel participants via videoconferencing software on the iPad. Using the detailed nutritional and physical activity feedback from the self monitoring programs, the dietitian will use SCT to engage the participants in order to initiate healthy behavior change whilst reducing the demands of commuting for in person nutritional counseling. Receives: Behavioral: Social Cognitive Theory |
| Intervention: Lifestyle B. | Other | Participants randomized to this group will receive 6 months of routine care followed by a delayed intervention. Lifestyle B will employ the same diet and physical activity prescription as Lifestyle A as described above.
Using Social Cognitive Theory, the study dietitian will counsel participants via videoconferencing software on the iPad. Using the detailed nutritional and physical activity feedback from the self monitoring programs, the dietitian will use SCT to engage the participants in order to initiate healthy behavior change whilst reducing the demands of commuting for in person nutritional counseling. Receives: Behavioral: Social Cognitive Theory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: Weight. Weight will be obtained using a single, calibrated scale.
Measured: Change from baseline in weight at 6 months
Primary outcome: Urinary sodium. We will estimate dietary sodium intake from a spot urine sample.
Measured: Change from baseline in Urinary sodium at 6 months
Primary outcome: Blood pressure. BP will be obtained using a mercury sphygmomanometer
Measured: Change from baseline in Blood pressure at 6 months
Primary outcome: Physical activity. Energy expenditures and minutes devoted to physical activity will be recorded using a FitBit.
Measured: Change from baseline in Physical activity at 6 months
Primary outcome: Serum Cystatin-C. Cystatin-C is a serum protein that is used as a biomarker of kidney function
Measured: Change from baseline in Cystatin-C at 6 months
Primary outcome: Lipoproteins. We will evaluate the impact of the intervention on serum lipids obtained after a 12-hour fast
Measured: Change from baseline in Lipoproteins at 6 months
Primary outcome: Serum Phosphorus and corrected Calcium-Phosphorus product (CaxPO4) will be evaluated from a venipuncture sample.
Corrected CaxPO4 is a measure of metastatic calcification, adjusted for the participant's nutritional status (serum albumin). When serum albumin is < 4 g/dL, the algorithm for corrected CaxPO4 is [Ca + 0.8(4 - serum albumin)]x PO4. When serum albumin if > 4 g/dL, corrected CaxPO4 = CaxPO4. CaxPO4 is obtained with routine monthly labs on all HD patients
Measured: Change from baseline in Serum Phosphorus and corrected Calcium-Phosphorus product at 6 months
Primary outcome: Serum Phosphorus and corrected Calcium-Phosphorus product (CaxPO4) will be evaluated from a venipuncture sample.
Corrected CaxPO4 is a measure of metastatic calcification, adjusted for the participant's nutritional status (serum albumin). When serum albumin is < 4 g/dL, the algorithm for corrected CaxPO4 is [Ca + 0.8(4 - serum albumin)]x PO4. When serum albumin if > 4 g/dL, corrected CaxPO4 = CaxPO4. CaxPO4 is obtained with routine monthly labs on all HD patients
Measured: Change from baseline in Serum Phosphorus and corrected Calcium-Phosphorus product at 12 months
Primary outcome: Weight. Weight will be obtained using a single, calibrated scale.
Measured: Change from baseline in weight at 12 months
Primary outcome: Urinary sodium. We will estimate dietary sodium intake from a spot urine sample.
Measured: Change from baseline in Urinary sodium at 12 months
Primary outcome: Blood pressure. BP will be obtained using a mercury sphygmomanometer
Measured: Change from baseline in Blood pressure at 12 months
Primary outcome: Physical activity. Energy expenditures and minutes devoted to physical activity will be recorded using a FitBit.
Measured: Change from baseline in Physical activity at 12 months
Primary outcome: Serum Cystatin-C. Cystatin-C is a serum protein that is used as a biomarker of kidney function
Measured: Change from baseline in Cystatin-C at 12 months
Primary outcome: Lipoproteins. We will evaluate the impact of the intervention on serum lipids obtained after a 12-hour fast
Measured: Change from baseline in Lipoproteins at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2015
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Ann Sevick, ScD, RN, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266823
- Sponsor's protocol ID
- 14-00563
- Status last verified
- Jan 2020
- First submitted
- 18 Sep 2014
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program to Improve Care in Complex Chronic Disease
- ClinicalTrials.gov ID
- NCT02266823
- Acronym / sponsor ID
- 14-00563
- Conditions
- Chronic Kidney Disease, Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 17 Oct 2014 (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.
The purpose of this study is to pilot test an mHealth technology-supported behavioral intervention designed to engage patients with diabetes and concurrent chronic kidney disease (CKD) in multiple behaviors which aim to reduce CKD progression. Participants will be randomized to the 6-month lifestyle intervention or to a wait-list control. The lifestyle intervention will be modeled after that used in the Diabetes Prevention Program (DPP) and the counseling intervention will be based on SCT, which will be paired with mobile technology-based dietary and physical activity monitoring. The wait-list control will receive 6 months of standard medical care followed by a delayed, but less intensive, 6-month intervention.
Detailed description
The purpose of this study is to develop and pilot test a lifestyle intervention in obese individuals with t2dm and concurrent stage 2-4 ckd. The counseling intervention will be based on social cognitive theory and supported by mobile (ipad) self-monitoring. Mobile self-monitoring is featured in the intervention to encourage vigilance to the diet in a manner that is not burdensome, enhance self-efficacy by integrating complex information regarding the ckd dietary regimen with a calorie-restricted diet, and permit real-time monitoring of weight, blood glucose, blood pressure, and self-reported diet and physical activity by the study team.
Specifically, the investigators will develop the methods for and pilot test the ckd lifestyle intervention in stage 2-4 ckd patients and explore the impact of the intervention on: (a) weight and fat mass, (b) blood pressure, (c) physical activity, (d) urinary sodium excretion, (e) serum phosphorus and calcium-phosphorus product, (f) kidney function as measured by serum cystatin-c, and (g) serum lipids. Additionally, we will evaluate the feasibility and acceptability of this intervention in terms of: (h) recruitment and retention, (i) time and cost associated with training ckd patients in technology-based self-monitoring and in delivering the intervention, (j) patterns of self-monitoring adherence over time, and (k) participant satisfaction with the intervention. Finally, we will describe: (l) the extent to which the intervention differentially adversely affects the nutritional health of participants as evidenced by low serum albumin or serum prealbumin; a body mass index (bmi) that falls below 20kg/m2; and subjective assessment of nutritional risk (e.g. Nausea, diarrhea, anorexia).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Lifestyle A. | Active comparator | Behavioral: Social Cognitive TheoryLifestyle A will receive an iPad loaded with a self-monitoring program used to support vigilance, reduce the information processing requirements, make readily available the information required to make good self-management decisions, provide real-time feedback, and permit targeted counseling in the context within which lifestyle behaviors occur. Using Social Cognitive Theory, the study dietitian will counsel participants via videoconferencing software on the iPad. Using the detailed nutritional and physical activity feedback from the self monitoring programs, the dietitian will use SCT to engage the participants in order to initiate healthy behavior change whilst reducing the demands of commuting for in person nutritional counseling. |
| Intervention: Lifestyle B. | Other | Behavioral: Social Cognitive TheoryParticipants randomized to this group will receive 6 months of routine care followed by a delayed intervention. Lifestyle B will employ the same diet and physical activity prescription as Lifestyle A as described above. Using Social Cognitive Theory, the study dietitian will counsel participants via videoconferencing software on the iPad. Using the detailed nutritional and physical activity feedback from the self monitoring programs, the dietitian will use SCT to engage the participants in order to initiate healthy behavior change whilst reducing the demands of commuting for in person nutritional counseling. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In order to be eligible for the study, the individual must be 40 years of age or older; have a DRG Code of T2DM, GFR of 15-89 ml/min/1.73m2 and a BMI >30 kg/m2. The participant's physician of record will have verified that his/her patient can safely participant in an intervention study that involves weight loss and a goal of 150 minutes/week of moderate physical activity (comparable to brisk walking).
Key exclusion criteria (4 listed)
- Those with the following characteristics will be excluded by the investigators:
- will exclude from the study those with underlying diseases which would increase the risk of participating in an intervention involving caloric restriction and physical activity. Such individuals would include those requiring treatment for cancer, exclusive of skin cancer other than melanoma, in the past 2 years; infectious diseases including untreated AIDS and active tuberculosis; uncontrolled hypertension of >190 mmHg SBP or >105 mmHg DBP despite treatment; stroke or TIA in the past 6 months; conditions requiring the use of home oxygen; or other chronic disease or condition likely to limit life span to < 1 year. A recent Institute of Medicine report suggests that reducing dietary sodium below 1,840 mg/day in those with mid- to late-stage heart failure may increase adverse events or mortality. Thus investigators will exclude those with heart failure.
- Because of the dietary requirements of a pregnant woman, and the nature of weight loss and gain with pregnancy, inclusion of pregnant women in the study would confound the study results. Those who become pregnant during the study will be withdrawn from the study.
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 |
|---|---|---|
| Social Cognitive TheoryAlso: SCTThe intervention, which combines behavioral counseling with mobile self-monitoring, will be based on SCT which focuses on the role played by self-referent thought in the maintenance of behavior change. Within SCT, behavior change and maintenance are influenced strongly by the individual's perceived self-efficacy. | Behavioural | Intervention: Lifestyle A., Intervention: Lifestyle B. |
Primary outcome
Primary outcome: Weight. Weight will be obtained using a single, calibrated scale.
Time frame: Change from baseline in weight at 6 months
Primary outcome: Urinary sodium. We will estimate dietary sodium intake from a spot urine sample.
Time frame: Change from baseline in Urinary sodium at 6 months
Primary outcome: Blood pressure. BP will be obtained using a mercury sphygmomanometer
Time frame: Change from baseline in Blood pressure at 6 months
Primary outcome: Physical activity. Energy expenditures and minutes devoted to physical activity will be recorded using a FitBit.
Time frame: Change from baseline in Physical activity at 6 months
Primary outcome: Serum Cystatin-C. Cystatin-C is a serum protein that is used as a biomarker of kidney function
Time frame: Change from baseline in Cystatin-C at 6 months
Primary outcome: Lipoproteins. We will evaluate the impact of the intervention on serum lipids obtained after a 12-hour fast
Time frame: Change from baseline in Lipoproteins at 6 months
Primary outcome: Serum Phosphorus and corrected Calcium-Phosphorus product (CaxPO4) will be evaluated from a venipuncture sample.
Time frame: Change from baseline in Serum Phosphorus and corrected Calcium-Phosphorus product at 6 months
Corrected CaxPO4 is a measure of metastatic calcification, adjusted for the participant's nutritional status (serum albumin). When serum albumin is < 4 g/dL, the algorithm for corrected CaxPO4 is [Ca + 0.8(4 - serum albumin)]x PO4. When serum albumin if > 4 g/dL, corrected CaxPO4 = CaxPO4. CaxPO4 is obtained with routine monthly labs on all HD patients
Primary outcome: Serum Phosphorus and corrected Calcium-Phosphorus product (CaxPO4) will be evaluated from a venipuncture sample.
Time frame: Change from baseline in Serum Phosphorus and corrected Calcium-Phosphorus product at 12 months
Corrected CaxPO4 is a measure of metastatic calcification, adjusted for the participant's nutritional status (serum albumin). When serum albumin is < 4 g/dL, the algorithm for corrected CaxPO4 is [Ca + 0.8(4 - serum albumin)]x PO4. When serum albumin if > 4 g/dL, corrected CaxPO4 = CaxPO4. CaxPO4 is obtained with routine monthly labs on all HD patients
Primary outcome: Weight. Weight will be obtained using a single, calibrated scale.
Time frame: Change from baseline in weight at 12 months
Primary outcome: Urinary sodium. We will estimate dietary sodium intake from a spot urine sample.
Time frame: Change from baseline in Urinary sodium at 12 months
Primary outcome: Blood pressure. BP will be obtained using a mercury sphygmomanometer
Time frame: Change from baseline in Blood pressure at 12 months
Primary outcome: Physical activity. Energy expenditures and minutes devoted to physical activity will be recorded using a FitBit.
Time frame: Change from baseline in Physical activity at 12 months
Primary outcome: Serum Cystatin-C. Cystatin-C is a serum protein that is used as a biomarker of kidney function
Time frame: Change from baseline in Cystatin-C at 12 months
Primary outcome: Lipoproteins. We will evaluate the impact of the intervention on serum lipids obtained after a 12-hour fast
Time frame: Change from baseline in Lipoproteins at 12 months
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 22 Jan 2020.
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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.
Mary Ann Sevick, ScD, RN principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Cognitive Theory in people with Chronic Kidney Disease and Diabetes, run by NYU Langone Health 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 1 inclusion and 4 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 22 Jan 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?
Primary outcome: Weight. Weight will be obtained using a single, calibrated scale. (time frame: Change from baseline in weight at 6 months). The study lists 14 primary outcomes in all. 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 22 Jan 2020.