Treatment Trials

12 Clinical Trials for Various Conditions

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COMPLETED
Reducing Sugar-sweetened Beverage Consumption Among Children
Description

Lowering sugar-sweetened beverage (SSB) consumption is a central component of lifestyle behavior change aimed at preventing and managing obesity, yet effective reduction of SSB intakes has been met with many challenges. While their palatability, accessibility, publicity, affordability, and social acceptability contribute to frequent and sustained SSB consumption, their caffeine and sugar content may further encourage continued intake. Although adverse health consequences of excessive SSB consumption are well documented, the extent to which their pleasant taste (due primarily to their sugar content) and post-ingestive effects (due to their sugar and/or caffeine content) positively reinforce consumption among children has not been elucidated. The purpose of this study is to conduct a pilot intervention to examine the feasibility of removing caffeinated SSBs from the child diet and to explore whether caffeinated SSB removal induces withdrawal symptoms in 8-11 (3rd-5th grade) year old children. Participants will be randomly assigned to replace their usual caffeinated SSB consumption with either caffeinated SSBs, caffeine-free SSBs or sparkling water provided by the study team for two weeks.

COMPLETED
Reducing Sugar-sweetened Beverage Consumption Among Young Adults
Description

This study aims to test sugar-sweetened beverage (SSB) health labeling elements in an online experiment to determine which elements are the most salient among young adults.

COMPLETED
Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents
Description

The primary aim of this study is to examine the effect of a multi-component intervention, designed to reduce consumption of sugar-sweetened beverages, on weight gain, total energy intake, and diet quality in adolescents. The secondary aim is to evaluate whether outcomes of the intervention differ between adolescents for whom 100% fruit juice vs. other products (i.e., soda, fruit punch, lemonade, iced tea, coffee drinks, energy drinks, sports drinks) constitutes the primary source of sugar from beverages.

COMPLETED
Testing Message Modality of Culturally Appropriate Nutrition Communication for Mexican American Women
Description

A randomized controlled trial to test the effects of culturally appropriate nutrition communication delivered via different modalities for Mexican American women.

COMPLETED
Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children
Description

This is a randomized clinical trial to test the efficacy of a parent-targeted text message-based intervention program on caries incidence and oral health behaviors (child and parent). Parents (n= 850) across all pediatric clinic sites (Boston Medical Center and Community Health Centers (CHCs); DotHouse CHC, South End Community Health Center, and Codman Square CHC) will be randomized to receive either text messages (TMs) regarding oral health or TMs regarding child wellness. The study will enroll English and Spanish speaking parents and their youngest child who is \< 7 years old, has at least one tooth showing, and attends the targeted pediatric clinic to receive primary care (n= 1700). Parents will complete self-report surveys at baseline, and 2, 4, 12, and 24-months after baseline; receive and respond to TM assessments during the 4-month intervention; and will also receive TMs during a 'booster' period of one month, which will occur 12-months post baseline. Parent's children will be assessed for caries by a clinical oral examination performed by licensed Clinical Examiners at baseline, 12-and-24-months post-baseline.

COMPLETED
A Community-based Study to Target Childhood Obesity
Description

The purpose of this study is to determine the efficacy of a community-based behavioral intervention (H2GO!) on decreasing sugar-sweetened beverage consumption and promoting water consumption among school-aged youth and parents/caregivers. We hypothesize that participants in the intervention site will demonstrate reduced sugar-sweetened beverage intake intake and increased water intake compared to participants in the comparison site at 2 and 6 months follow-up.

Conditions
COMPLETED
Intervention to Reduce Sugar-Sweetened Beverage (SSB) Consumption in Children and Families
Description

Pilot randomized trial of a technology-based intervention to reduce sugary drink consumption and promote water intake in families with young children.

COMPLETED
Online Study of the Effects of Sugary Drink Warning Labels on Consumption
Description

The aim of this study is to determine the degree to which sugar-sweetened beverages (SSB) warning labels increase consumers' knowledge about the potential health harms of SSBs and reduce SSB purchases and consumption. 216 racially and ethnically diverse parents of children 6-11 years old will be recruited to buy snacks and beverages for four weeks via an online store that ships participants their purchases. Participants will be randomized to either 1) calorie labels (control); or 2) sugar graphic warning labels. The investigators hypothesize that sugar graphic warning labels displayed in an online store in weeks 2-4 will lead to the greatest reductions from week 1 across both primary outcomes compared to the control group that will only see calorie labels.

COMPLETED
Are Sugar-Sweetened Beverage Information Labels Well-Targeted
Description

We will study the extent to which soft drink information labels -- designed to curb unhealthy consumption -- are well-targeted to the most biased consumers.The study team will deploy novel methods for evaluating the targeting properties of information labels via an incentive-compatible online shopping experiment. At a high-level, we will ask whether the treatment effects of the information labels are concentrated on individuals with the biggest self-control problems and with the least knowledge of nutrition. We will first use the methodology from Allcott et al. (2019) to estimate the internality for each participant. We will then have participants make shopping decisions for soft drinks, first absent any information labels and then, for those not in the control group, in the presence of an information label. The within-subject design of the soft drinks experiment will allow us to estimate how the effects of the labels covary with consumers' internalities, and thus to determine whether the labels are well-targeted.

COMPLETED
Effectiveness of an IMB-based Intervention for Reducing Sweetened Beverages Consumption in Preschool Children
Description

Sugar-sweetened beverages and over consumption of 100% fruit juice add unneeded calories to the diets of children, potentially leading to overweight. As children's diets are extensions of their parent's behaviors, the investigators propose to implement a nutrition education intervention based on the Information-Motivation-Behavioral Skills (IMB) behavior change model using parents as the primary agent of change. This project will evaluate an intervention to reduce sugar-sweetened beverages in preschool children from low-resource families. The proposed research uses a randomized control group design involving 20 parents of 3-5-year-old children at 20 sites (n=400) over 3 years. The investigators will randomly assign sites to two experimental conditions: 1) 10-week sugar-sweetened beverage intervention and 2) 10-week sham education control. Data collection for the two groups will be conducted at baseline and 1 weeks and 6 months post intervention. Measures to be collected include and IMB survey, home beverage inventory (HBI), weekend food recall, and anthropometrics. Education programs will be available to all parents at sites through interactive display boards with 5-10-minute lessons. Each semester 8 students (n=32) will enroll in an experiential course aimed at increasing students' cultural competency. For 10 weeks, students will attend classroom training and spend 2 hours twice a week at sites implementing the nutrition education program.

ENROLLING_BY_INVITATION
Water is K'é: Multi-level Intervention to Promote Healthy Beverage Choices Among Navajo Families
Description

The goal of this clinical trial is to understand if a cultural intervention for Navajo families will improve healthy beverage habits, health outcomes, and family cohesion. The main questions it aims to answer are: * Does Water is K'é results in healthier beverage habits among children aged 2 to 5, compared with children in a control group? * Does the intervention improve the health of other family members? * How does the intervention affect family well-being? Participants will take part in a four-month program at the early child education site (such as a Head Start or the Bureau of Indian Affair's Family and Child Education or FACE Program) where the child is enrolled. They will take part in lesson plans, a social media campaign, and a family water access plan. Researchers will compare the participating families with families at wait-list early child educations sites. We will collect information through surveys, health measurements, and qualitative interviews and compare results to learn if Water is K'e improves health behaviors, health outcomes, and family cohesion.

ACTIVE_NOT_RECRUITING
A Cluster Randomized Trial of the H2GO! Program
Description

This proposal involves a collaboration with the Massachusetts Alliance of Boys and Girls Clubs. The goal is to evaluate the efficacy of youth empowerment intervention targeting sugar-sweetened beverage consumption on childhood obesity among youth. The 12-session 6-week intervention consists of health and narrative sessions and youth-led activities. For this cluster randomized controlled trial \[RCT} at 10 sites, the investigators will recruit 45 parent-child pairs per site for a total of 450 parent-child pairs. The primary outcome is child participants' body mass index (BMI) z scores. Secondary outcomes include children's sugar-sweetened beverage intake, water intake, and youth empowerment. Change in outcomes over time among participants in the intervention sites will be compared to change in outcomes over time among participants