Intervention Program for Weight Gain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Duke University - with Piedmont Health Services, Inc., Durham, NC
Weight Gain+5 More
Intervention Program - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a digital health platform can help prevent weight gain in obese patients.

See full description

Eligible Conditions

  • Weight Gain
  • Overnutrition
  • Overweight
  • Signs and Symptoms
  • Nutrition Disorders
  • Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Weight Gain

Study Objectives

This trial is evaluating whether Intervention Program will improve 1 primary outcome and 3 secondary outcomes in patients with Weight Gain. Measurement will happen over the course of baseline, 24 months post-randomization (up to 27 months to obtain 24 month data).

Month 27
Intervention cost-effectiveness
Month 27
Change in Framingham risk score
Change in blood pressure
Change in weight

Trial Safety

Safety Progress

1 of 3

Other trials for Weight Gain

Trial Design

2 Treatment Groups

Usual Care Program
1 of 2
Intervention Program
1 of 2
Active Control
Experimental Treatment

This trial requires 443 total participants across 2 different treatment groups

This trial involves 2 different treatments. Intervention Program is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention Program
Behavioral
Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dieticians serving as health coaches within a local network of community health centers.
Usual Care ProgramBalance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention Program
2010
N/A
~6880

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months post-randomization (up to 27 months to obtain 24 month data)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 months post-randomization (up to 27 months to obtain 24 month data) for reporting.

Closest Location

Duke University - with Piedmont Health Services, Inc. - Durham, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients of Piedmont Health Services' community health centers in central North Carolina only
BMI between 25 and 40 kg/m2 and weighs less than 380 lbs
Speaks English or Spanish
Had a non-urgent outpatient visit at a participating community health center clinic at Piedmont Health Services within the last 2 weeks
Has a cell phone
Willing to receive 3-12 study-related text messages per week

Patient Q&A Section

What is weight gain?

"Obesity is becoming a growing health problem amongst children and adult populations in the United States. The underlying cause for this growing epidemic is often a result of a combination of factors; however, one of the major reasons is an improper diet. It is estimated that roughly 50% of American adults (aged 20+ years) and 20-50% of children are considered obese.\n" - Anonymous Online Contributor

Unverified Answer

Can weight gain be cured?

"An unhealthy diet, increased physical activity, and regular medical screening were associated with a decreased risk of weight gain in obese adults who switched from a high-fat/high-calorie diet to the Mediterranean diet. However, weight gain did occur in this well-studied intervention population, and was associated with decreased quality of life, fatigue, anxiety, and depression. In a recent study, findings underscore the need for additional randomized studies to define the long-term health effects of these dietary and behavioral changes." - Anonymous Online Contributor

Unverified Answer

What causes weight gain?

"It is evident that weight gain is a risk factor for diabetes and some other insulin-resistant diseases, but a cause of diabetes remains elusive. This suggests that alterations in diet and/or exercise may prevent diabetes by enhancing insulin sensitivity and glucose metabolism." - Anonymous Online Contributor

Unverified Answer

What are common treatments for weight gain?

"Effective solutions for weight gain vary widely across health systems. Diet and exercise are considered the preferred and effective therapies, as long as the nutritional demands and risks are taken into account. Furthermore, there are several methods of preventing weight gain. This information, as presented to the public through public health interventions and medical literature, is essential for people facing problems of weight gain, as well as their families, medical professionals, employers and employers." - Anonymous Online Contributor

Unverified Answer

What are the signs of weight gain?

"People with obesity have a significantly higher risk of developing metabolic syndrome and T2DM. Weight gain has been identified as a risk factor for the development of both metabolic syndrome and T2DM in obese children and adults." - Anonymous Online Contributor

Unverified Answer

How many people get weight gain a year in the United States?

"About 11% of American adults will gain more than 5 pounds a year from age 18 to 66, and women are more likely than men to be at risk." - Anonymous Online Contributor

Unverified Answer

Is intervention program safe for people?

"Recent findings suggests that a primary health care based program can result in a significant decrease in the percentage of people with obesity over 6 months of follow-up compared to the control group (P-value = 0.008). However, the absolute reduction in waist-hip ratio is still small (~0.50 cm). Further evaluation will be required to assess whether it is an effective intervention for primary weight control in the real world setting." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating weight gain?

"Very few studies reported results suggesting weight loss was an effective treatment. A large multicentre clinical trial of patients with T2DM is urgently needed. A study of long-term outcomes is also required. For patients with diabetes, a meta-analysis of RCTs comparing treatments other than SGLT2 inhibitors and GLP-1 analogues with agents that were approved, found little evidence for superiority.[Power-Effectiveness (p) (http://www.withpower.com/clinical-trials/diet-weight-loss/weight-loss-for-diabetes-combination-p-10." - Anonymous Online Contributor

Unverified Answer

How does intervention program work?

"We suggest that the benefits of an intervention program are not only due to the specific content of programs. They result from a change in social norms which affect the behavior of individuals in relation to those norms. Given that social norms in people with diabetes are mostly related to perceived diabetes knowledge and perceived diabetes control, our results suggest that interventions promoting these specific social norms may be of added value to the standard care provided to people with diabetes." - Anonymous Online Contributor

Unverified Answer

Does intervention program improve quality of life for those with weight gain?

"Interventions, especially structured weight control programs, are associated with improved HRQOL, lower weight, and higher HbA1c levels after the intervention. The associations between improvements in HRQOL and diabetes care outcomes in the intervention group should be confirmed by future investigations." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of intervention program?

"For more than half of our sample, most of their comorbidities disappeared or were controlled by the intervention program. Most commonly, side effects were mostly moderate, transient, and tolerable. Therefore, we recommend that patients and physicians are prepared to tolerate most side effects of intervention, especially moderate and tolerable ones. However, more long-term follow up is required." - Anonymous Online Contributor

Unverified Answer

What does intervention program usually treat?

"The overall intervention program in [Tongji] Hospital is based on the principle of [Integrated Clinical and Rehabilitative Physiotherapy] (IcPRP) developed by Fang (2007). IcPRP is a type of rehabilitative physiotherapy [method] aiming to improve patients' physical function. In Tongji Hospital, IcPRP mainly [includes] rehabilitative physiotherapy [techniques] that are specially developed for [patients with] neurology [and stroke]." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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