What side effects are associated with this type of intervention?

Behavioral interventions for weight loss, such as sequential group programs involving parents and children, are generally well-tolerated with minimal side effects. Common side effects may include initial discomfort or resistance to behavior changes, mild psychological stress due to lifestyle adjustments, and potential temporary increases in anxiety or depressive symptoms as individuals adapt to new routines. However, these side effects are typically transient and can be managed with proper support and guidance from healthcare providers.

What other types of research exist?

Promising, novel alternatives for weight loss patients include: 1) Internet-based guided self-help programs, which have shown efficacy in reducing binge eating episodes and maintaining benefits post-treatment. 2) Smartphone applications like Noom Monitor, which assist with self-monitoring and have been effective in augmenting guided self-help CBT. 3) Online guided self-help family-based treatment (GSH-FBT), which has demonstrated feasibility and effectiveness in improving clinical outcomes for adolescents with anorexia nervosa and could be adapted for weight loss interventions.

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iAmHealthy Program for Family Obesity Management

Q: What prior FDA approvals exist?

The FDA has approved several medications for weight loss, including orlistat, phentermine-topiramate, naltrexone-bupropion, and liraglutide. These medications are often used in conjunction with lifestyle modifications such as diet and exercise. Behavioral interventions, like the Parent-Only Group Program followed by Parent and Child Group Program, focus on lifestyle changes and have shown effectiveness in managing weight. These programs emphasize the importance of family involvement and behavioral strategies to support sustainable weight loss.

N/A

Recruiting

Led By Ann M Davis, PhD, MPH

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month and 10 months

Awards & highlights

Summary

This trial is testing if starting with a program just for parents before doing a program for both parents and children together helps parents adopt healthy habits first so they can better support their children. The study targets parent/child pairs from rural areas in Kansas and neighboring states.

Who is the study for?

This trial is for families in rural Kansas with a child aged 6-11 who's overweight and parents also above a healthy weight. They must speak English and be available when the program is scheduled. Families can't join if the parent has had recent serious health issues, surgery for weight loss, or pregnancy; or if there are cognitive impairments or plans to move away.

What is being tested?

The study tests whether an obesity program that starts with just parents before including children is more effective than one involving both from the start. It uses televideo sessions aimed at improving family health habits.

What are the potential side effects?

Since this trial involves educational programs rather than medication, traditional side effects aren't expected. However, participants may experience changes in lifestyle that could affect daily routines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month and 10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month and 10 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month and 10 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent weight change in parents and BMIz (BMI z-score) in children

Secondary study objectives

Mediator: Attendance

Mediator: Reciprocal modeling

Moderator: Family functioning

+1 more

Other study objectives

Participation rates and representativeness of school and clinic samples

The impact of nurse engagement/leadership on participant reach and attendance as measured by the Community Engagement Survey and semi-structured interviews

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: iAmHealthy Parents FirstExperimental Treatment1 Intervention

iAmHealthy Parents First families will take part in a group program with other adults over Zoom. Children will not be involved during this time. Adults will participate in these group sessions weekly for three months. Each meeting will last approximately an hour. Fifteen dyads from each cohort will be randomized to the iAmHealthy Parents First group. After 3 months, both iAmHealthy Parents First and iAmHealthy families will take part in an educational group program with parents and their children. These meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur three weeks out of four for four months. There will be three additional family-based group sessions spread over the final two months of the program. iAmHealthy Parents First adults will continue to meet monthly during the family-based program (on weeks when the family-based group does not meet) to continue the adult program.

Group II: iAmHealthyActive Control1 Intervention

iAmHealthy families will receive an informational newsletter once a month for three months. This group will be given the flexibility to start their weight loss journey using self-guided methods. No formal group sessions will be provided for three months. Fifteen dyads from each cohort will be randomized to the iAmHealthy group. After 3 months, both iAmHealthy Parents First and iAmHealthy families will take part in an educational group program with parents and their children. These meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur three weeks out of four for four months. There will be three additional family-based group sessions spread over the final two months of the program.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common weight loss treatments, particularly behavioral interventions like the Parent-Only Group Program followed by Parent and Child Group Program, work by modifying eating behaviors, increasing physical activity, and addressing psychological factors. These programs use psychoeducation, cognitive-behavioral strategies, and motivational interviewing to help patients adopt healthier lifestyles. Starting with parents helps create a supportive home environment and equips them to model and reinforce healthy behaviors in their children. This approach is crucial for sustainable weight loss, improved family dynamics, and enhanced intervention effectiveness.

Development of a group therapy to enhance treatment motivation and decision making in severely obese patients with a comorbid mental disorder.[Family-oriented group therapy in the treatment of female patients with anorexia and bulimia nervosa--a pilot study].Stepped care treatment for eating disorders.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,765 Previous Clinical Trials

8,133,031 Total Patients Enrolled

33 Trials studying Weight Loss

2,849 Patients Enrolled for Weight Loss

University of Kansas Medical CenterLead Sponsor

488 Previous Clinical Trials

171,975 Total Patients Enrolled

10 Trials studying Weight Loss

102,277 Patients Enrolled for Weight Loss

National Institute of Nursing Research (NINR)NIH

598 Previous Clinical Trials

10,377,682 Total Patients Enrolled

3 Trials studying Weight Loss

777 Patients Enrolled for Weight Loss

Media Library

iAmHealthy Parents First Clinical Trial Eligibility Overview. Trial Name: NCT05612971 — N/A

Weight Loss Research Study Groups: iAmHealthy Parents First, iAmHealthy

Weight Loss Clinical Trial 2023: iAmHealthy Parents First Highlights & Side Effects. Trial Name: NCT05612971 — N/A

iAmHealthy Parents First 2023 Treatment Timeline for Medical Study. Trial Name: NCT05612971 — N/A

~131 spots leftby Apr 2025

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